#Neuromyelitis Optica Spectrum Disorder (NMOSD) Market

[aadeshmmr]

The global Neuromyelitis Optica Spectrum Disorder market was estimated at USD 410.5 million in 2022, and revenue is predicted to increase by 6.15% between 2023 and 2029, reaching roughly USD 623.38 million.

[the-rachana]

MOG Antibody Associated Disorders Treatment Market to grow at a CAGR of over 3.7% from 2023 to 2031, reveals Growth Plus Reports

According to the deep-dive market assessment study by Growth Plus Reports, the global MOG antibody associated disorders treatment market is expected to register a revenue CAGR of 3.7% during the forecast period from 2023 to 2031.

MOG Antibody Associated Disorders Treatment Market Fundamentals

The immunoglobulin (Ig) superfamily member myelin oligodendrocyte glycoprotein (MOG) is a myelin protein that is expressed at the outermost lamellae of myelin sheath and oligodendrocyte (OGD) membranes. In various neurological conditions, including multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and acute disseminated encephalomyelitis, MOG is a target of autoantibodies. The MOG antibody associated disorders treatment is not entirely apparent and is mostly based on neuromyelitis optica spectrum disorders experience. Any prescription is made off-label because there are currently no approved medications for long-term prevention of recurrence in adult MOG antibody associated disorders patients. However, recent research has indicated that treating MOG antibody associated disorders patients with immunosuppressive drugs such as mycophenolate mofetil and rituximab has positive outcomes. The best course of action for treating this rare autoimmune illness will require further study. In clinical practice, the choice to begin long-term relapse prevention treatment is dependent on the likelihood of subsequent relapses, the opportunity for recovery, and the persistence of MOG-IgG over time. In this context, rituximab, human intravenous (IV) IgG, azathioprine (AZA), and mycophenolate mofetil are the most frequently utilized therapies for adult MOG antibody associated disorder patients.

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MOG Antibody Associated Disorders Treatment Market Dynamics

The increased prevalence of the MOG antibody associated disorders is the most important factor supporting the MOG antibody associated disorders treatment market demand. According to research, the anti-MOG antibody is present in between 40% and 58% of kids who have been diagnosed with acute disseminated encephalomyelitis. Even though MOG antibody associated disorders, neuromyelitis optica spectrum disorders, and acute disseminated encephalomyelitis share many similarities, it seems that MOG antibody associated disorders are distinct immunological illnesses. The prevalence and importance of immune-mediated inflammatory disorders (IMIDs) are rising in contemporary society and significantly affect the patient and the healthcare system. Increased emergence of these diseases triggers the development of MOG antibody associated disorders. Therefore, advanced therapeutics, robust pipeline drugs, and novel treatment strategies are the current opportunities for the MOG antibody associated disorders treatment market. Therefore, MOG antibody associated disorders treatment market trends are urgently needed to address the growing burden of MOG antibody related disorders and improve patient outcomes. Additionally, further research is necessary to understand these diseases' underlying mechanisms better and identify potential intervention targets.

However, steroids are most frequently administered as a first line treatment for MOG antibody associated disorders treatment. These steroids have multiple side effects which restrict the growth of the MOG antibody associated disorders treatment market.

MOG Antibody Associated Disorders Treatment Market Ecosystem

This report provides the global MOG antibody associated disorders treatment market analysis in terms of revenue, market growth, market dynamics, regional landscape, and overall competitive positioning of the major market players. The global MOG antibody associated disorders treatment market is analyzed from the following perspectives: Drug Class, Distribution Channel, and Region.

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MOG Antibody Associated Disorders Treatment Market by Drug Class

Based on the drug class, the global MOG antibody associated disorders treatment market is segmented as corticosteroids, immunosuppressants, intravenous immunoglobulin, and others.

Intravenous steroids are frequently used for the treatment of MOG antibody associated disorders. Corticosteroids are the most effective treatment for reducing primary symptoms and preventing disease progression. The easy availability of corticosteroids is also a crucial factor for driving segmental growth. Corticosteroids rapidly decrease inflammation associated with MOG antibody associated disorders, for which it is frequently prescribed therapeutics for MOG antibody associated disorders.

Intravenous immunoglobulin maintenance (IVIG) may be an effective treatment for preventing relapse in MOG antibody associated disorders. Future market growth is projected to be aided by the rising use of immunoglobulin due to new product introductions and regulatory approvals. Accessibility and cost-effectiveness may also impact how frequently intravenous immunoglobulin is used as a therapeutic option.

MOG Antibody Associated Disorders Treatment Market by Distribution Channel

Based on the distribution channel the global MOG antibody associated disorders treatment market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.

The hospital pharmacies segment accounted for the largest revenue share of the global MOG Antibody Associated Disorders Treatment market in 2022. Since MOG antibody-associated disorders is a rare disease, specialist knowledge and skill are needed to diagnose and treat this condition. As hospital pharmacies may have access to the most recent research and treatments, MOG antibody associated disorders patients may benefit from receiving care at a hospital with a specialist clinical staff with experience treating this illness.

MOG Antibody Associated Disorders Treatment Market by Region

Based on the region, the global MOG antibody associated disorders treatment market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America accounted for the largest revenue share of the global MOG antibody associated disorders treatment market in 2022. The streamlined repayment laws in North America and an increase in the occurrence of MOG antibody associated disorders are expected to assist the growth of the MOG antibody associated disorders treatment market in North America. The market for advanced healthcare services in the region is reportedly driven by several factors, including a well-established healthcare infrastructure, industry heavyweights, recently released cutting-edge instruments, payment coverage, and more. The growing population and knowledge of modern healthcare services and the rise in disposable income are also anticipated to contribute to North America's market growth.

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MOG Antibody Associated Disorders Treatment Market Competitive Landscape

The potent drug pipeline is giving this market a big boost. The pharmaceutical industry is spending a lot on research and development to create new medications to meet the rising demand. Market participants are implementing various methods, including distribution, mergers and acquisitions, and other cooperative arrangements, to increase their market penetration and share. Different industry companies are also being influenced to invest due to the increased prevalence of MOG antibody-associated illnesses and the rising demand for cutting-edge treatments. In the upcoming years, innovative therapeutics and customized medicine are anticipated to accelerate market growth further. Notable market participants holding the largest share of the global MOG antibody associated disorders include,

 • AstraZeneca Plc

• Merck & Co., Inc.

• GlaxoSmithKline Pharmaceuticals Ltd.

• Novartis AG

• Pfizer Inc.

• Biotest AG

• Baxter International Inc.

• Octapharma AG

• LFB Biotechnologies

• Grifols SA

• CSL Behring

• China Biologics Products Inc.

• Kedrion Biopharma

• BDI Pharma Inc.

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[mi-researchreports]

Neuromyelitis Optica Spectrum Disorder Market is poised to grow at CAGR of 6 % by 2027. Factors driving Neuromyelitis Optica Spectrum Disorder Market are increasing incidence and prevalence of neuromyelitis optica spectrum disorder (NMOSD), increasing research.

[pharmaphorumuk]

Alexion finally has a buyer – and it’s AstraZeneca with $39bn on the table

Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and that was a good call – AstraZeneca has just swooped in with $39 billion cash-and-stock takeover offer.

The deal – the largest in the pharma sector since the start of the pandemic – bolsters AZ’s immunology franchise with $4 billion blockbuster Soliris (eculizumab) and longer acting follow-up Ultomiris (ravulizumab), plus a pipeline of 11 drugs for rare and autoimmune diseases.

The transaction values Alexion at $175 per share, a sizeable 45% premium on its closing price on Friday, the day before the deal was announced.

Alexion shareholders will receive $60 in cash, plus 2.12 of AZ’s US-listed shares for each share they hold, ending up owning around 15% of the combined company.

Analysts at SVB Leerink said that while the offer is fair at that price, Alexion is a “scarce and high-quality asset,” which could prompt an offer from another company. In the past, Novartis, Roche, Pfizer and Amgen have all been mentioned as potential suitors.

It marks something a departure from AZ’s relentless focus on deal-making in oncology, its top product category, and also comes as Alexion has been locked in a battle with activist shareholders pushing for a sale.

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

The threat of biosimilar competition to its cash cow has weakened Alexion’s share price, providing an opportunity for AZ, which has been rumoured to be angling for a large acquisition for several months.

While the first biosimilars to Soliris have already reached the market in some countries like Russia, Alexion cut a settlement deal with Amgen in the summer that prevents the latter’s biosimilar version of Soliris from entering the US market until 2025, avoiding a near-term cash cliff.

In the meantime, Ultomiris has been gathering momentum, fuelled by intravenous dosing every eight weeks, rather than every two weeks with Soliris. It racked up $340 million in sales last year, and added another $763 million in the first nine months of this year, backing up its blockbuster credentials.

Soliris was the first drug to become available for each of its approved indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD).

Ultomiris is already approved for PNH and aHUS and in late-stage development for NMOSD, which could lend further momentum.

Meanwhile, AZ will also picks up three other drugs – Strensiq (asfotase alfa) for hypophosphatasia, Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency (LAL-D) and anticoagulant reversal agent Andexxa (andexanet alfa) – that collectively brought in almost $675 million in the first nine months of 2020.

AZ is taking on debt to fund the deal but should pay that off quickly given Alexion should book double-digit growth in the coming years, which could be enhanced by AZ’s broader footprint in Europe and Asia.

Alexion has been working hard to flesh out is pipeline as well, snapping up Achillion Pharma, Syntimmune, Wilson Therapeutics and Portola and forging an alliance with gene-silencing specialist Dicerna focusing on complement diseases.

Along with  new indications for its existing drugs, the Swiss biopharma has four more drugs in phase 3 development that could benefit from the increased financial and development muscle that AZ will bring to the table.

That includes ALXN1840 for genetic disorder Wilson disease, with results due in the first half of next year, as well as CAEL-101 for light chain amyloidosis, AG10 for ATTR cardiomyopathy and ALXN2040 or PNH patients with extravascular haemolysis (EVH).

“Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases,” said AZ’s chief executive Pascal Soriot.

“This acquisition allows us to enhance our presence in immunology,” he added. “We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.”

The combined company will be able to carve around $500 million a year off its cost base, and will deliver double-digit growth average annual revenue growth through 2025, providing cash flow to reinvest in R&D, said the two companies in a statement.

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[kunalcmi]

OPTIC NERVE DISORDERS TREATMENT MARKET ANALYSIS (2019-2027)

Optic nerve disorder is a medical condition that indicates degeneration of the optic nerve. There are many types of optic nerve disorders such as glaucoma, optic neuritis, and optic nerve atrophy. Antibiotics such as ethambutol, isoniazid, and tetracycline cause optic neuritis. Steroid-based drugs such as methylprednisolone, which is a synthetic corticosteroid used intravenously as an anti-inflammatory and immunosuppressant agent are in the clinical practice and generally preferred by the physicians.

 In most of cases, there is no treatment available for optic nerve damage that can restore sight but can stop further worsening of the symptoms. The patient who are diagnosed with glaucoma can use eye drops, undergo eye surgery such as laser therapy, and oral medication.

 Global Optic Nerve Disorders Treatment Market Drivers

Increasing number of drug approvals by the U.S. Food & Drug Administration (FDA) for treatment of optic nerve disorders are expected to drive growth of the optic nerve disorders treatment market. For instance, in 2019, Eculizumab, which is a first monoclonal antibody drug that target C5 node of the nerve was approved by the U.S. FDA. In addition, Eculizumab is used for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD).

Moreover, Bausch & Lomb, a leading global eye health company) and Nicox S.A. received the U.S. FDA approval for VYZULTA, in 2017. VYZULTA is a first prostaglandin analog with one of its metabolites being nitric oxide (NO) and is used for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma.

Furthermore, in 2017, Aerie Pharmaceuticals received the U.S. FDA approval of Rhopressa.  In addition, Rhopressa also used in lowering of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Therefore, approval of Eculizumab, VYZULTA, and Rhopressa drug are expected to drive growth of the optic nerve disorders treatment market.

In 2019, Santhera Pharmaceuticals announced about successful completion of its clinical trial (Phase IV) of Raxone drug, used for the treatment of hereditary optic neuropathies. It is expected to be marketed by 2021. Increasing prevalence of vision impairment or blindness among people is the factor that is expected to boost growth of the global optic nerve disorders treatment market. For instance, according to WHO, in 2019, over one billion people suffered from vision impairment globally. In addition, changing lifestyle of the people and limited access to eye care especially in the emerging countries are the main driving factors for rising numbers of people with vision impairment.

 Global Optic Nerve Disorders Treatment Market Restraints

However, side effects associated with optic nerve disorders drugs for the treatment of the disease such as glaucoma, optic neuritis are the factors that are expected to hamper growth of the global optic nerve disorders treatment market. For instance, potential side effects of the prostaglandin analogs drug (Xalatan) that are used for the treatment of glaucoma are eye color change, darkening of eyelid skin, eyelash growth, droopy eyelids, sunken eyes, stinging, eye redness, and itching. Moreover, side effects of steroid drugs (Methylprednisolone), which is used for the treatment of optic neuritis include eye infection, mood changes, and weight gain.

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  Global Optic Nerve Disorders Treatment Market Regional Analysis

 North America is expected to account for highest market share in global optic nerve disorder treatment market due to increasing number of approval of drug by U.S FDA. In 2019, Alexion Pharmaceutical, Inc. received approval of the SOLIRIS drug by U.S. Food and Drug Administration (FDA), for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients, who are anti-aquaporin-4 (AQP4) antibody positive. In addition, about 73% of patient suffering from the Neuromyelitis Optica Spectrum Disorder (NMOSD) has responded positively for anti-AQP4 auto-antibodies. Moreover, Neuromyelitis optica spectrum disorder is mostly found in young women. In the U.S., most of the patient are recorded to be diagnosed with NMOSD. Furthermore, European Medicines Agency and Japanese Ministry of Health, Labor, and Welfare are trying to assess applications of SOLIRIS for the treatment of NMOSD. These factors are expected to propel growth of the global optic nerve disorder treatment market.

 Moreover, increasing prevalence of eye disorders in the region is another factor that is expected to drive growth of the optic nerve disorders treatment market. For instance, according to the American Academy of Ophthalmology, in 2019, around 7.32 million people is expected to suffer from the primary open-angle glaucoma (POAG), with the highest number among populations aged 70 to 79 years (32%), women (50%), and Hispanics (50%).

 Global Optic Nerve Disorders Treatment Market Competitive Analysis -

 Key players operating in the global optic nerve disorder treatment market include Santen Pharmaceutical Co., Ltd., Allergan plc, Novartis International AG, Pfizer, Inc., Bausch Health Companies, Inc., Aerie Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., Bionure Farma, S.L., and Mallinckrodt Pharmaceuticals.

 Market Taxonomy:

On the basis of drug class, the global optic nerve disorders treatment market is segmented into:

Steroids

Analgesics

Parasympathomimetics

Beta-blockers & Alpha-adrenergic Agonists

Carbonic Anhydrase Inhibitors

Others

On the basis of distribution channel, the global optic nerve disorders treatment market is segmented into:

Hospital Pharmacies

Clinics

Retail Pharmacies

Online Pharmacies

On the basis of region, the global optic nerve disorders treatment market is segmented into:

North America

Latin America

Europe

Middle East

Asia Pacific

Africa

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[kritikarehani]

Neuromyelitis Optica Spectrum Disorder (NMOSD) Gender-based Epidemiology

Neuromyelitis Optica Spectrum Disorder (NMOSD) is more common among females as compared to males.

Source: https://www.delveinsight.com/report-store/neuromyelitis-optica-spectrum-disorder-nmosd-market

[databridgemarketresearchblog]

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market 2020 Industry Research, Share, Trend, Industry Size, Price, Future Analysis, Regional Outlook to 2026 Research Report | DBMR Updates

This Neuromyelitis Optica Spectrum Disorder (NMOSD) Market research document predicts the size of the market with information on key vendor revenues, development of the industry by upstream & downstream, industry progress, key companies, along with type segment & market application. This market study takes into account a market attractiveness analysis, where each segment is benchmarked based on its market size, growth rate, and general attractiveness. Another major section of this Neuromyelitis Optica Spectrum Disorder (NMOSD) Market report is the competitive landscape which provides a clear insight into the market share analysis and actions of key industry players. Quality and transparency is strictly maintained while carrying out research studies to offer an exceptional market research document for your niche.

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All the data of this market report is exceptionally useful to the clients and businesses for making decisions related to revenue, investment, import, export and consumption. To meet the strategic as well as specific needs of the organization or business, a comprehensive market research document such as this Neuromyelitis Optica Spectrum Disorder (NMOSD) Market report, has to be in place. Geographical scope of the products is also carried out comprehensively for the major global areas such as Asia, North America, South America, and Africa which helps define strategies for the product distribution in those areas. Competitive landscape is explored in terms of product range, strategies, and future prospects of the key players of the Healthcare industry.

Market Analysis: Besides target market information, DBMR also provides information about your competitor, your customers, products etc. A few techniques we use are: Customer analysis Competitor analysis Risk analysis Product research Advertising research E-mail survey and many more…

Market Analysis and Insights: Global Neuromyelitis Optica Spectrum Disorder (NMOSD) Market

Global neuromyelitis optica spectrum disorder (NMOSD) market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market is growing at a healthy CAGR in the above-mentioned research forecast period. Emerging markets and huge investment in research and development are the factors responsible for the growth of this market.

The major players covered in the global neuromyelitis optica spectrum disorder (NMOSD) market are F. Hoffmann-La Roche Ltd, Novartis AG, Hikma Pharmaceuticals Plc, Mylan N.V., AstraZeneca, Teva Pharmaceutical Industries Ltd, Alexion Pharmaceuticals, Inc, Viela Bio, Anvil Biosciences, Opexa Therapeutics, Inc, Arrien Pharmaceuticals, LLC, TG Therapeutics, Inc, Bionure Farma, S.L., and others.

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The global neuromyelitis optica spectrum disorder (NMOSD) market is majorly driven by the high incidence of neuromyelitis optica spectrum disorder (NMOSD) and promising pipeline drugs portfolio. In addition, emergence of drugs used in the prevention of neuromyelitis optica spectrum disorder (NMOSD) and improvement in healthcare facilities are some of the impacting factors that drives the market growth. Nevertheless, less trained expertise or technically skilled professionals coupled with high treatment cost significantly hinder the growth of this market.

Neuromyelitis optica spectrum disorder (NMOSD) is previously known as devic syndrome is a rare, lifelong and inflammatory autoimmune disease of the central nervous system that damages the optic nerve as well as spinal cord. The characteristics signs and symptoms of neuromyelitis optica spectrum disorder (NMOSD) is optic nerve inflammation which eventually leads to the loss of clear vision.

Global neuromyelitis optica spectrum disorder (NMOSD) market provides details of market share, new developments and product pipeline analysis, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions and technological innovations in the market. To understand the analysis and the market scenario contact us for an Analyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Global Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Scope and Market Size

Global neuromyelitis optica spectrum disorder (NMOSD) market is segmented on the basis of type, treatment type, route of administration, end-users and distribution channel.

The global neuromyelitis optica spectrum disorder (NMOSD) market is segmented on the basis of type into neuromyelitis optica spectrum disorder with aquaporin-4 antibodies and neuromyelitis optica spectrum disorder without aquaporin-4 antibodies

Based on treatment type, the global neuromyelitis optica spectrum disorder (NMOSD) market is segmented into medication, plasma exchange therapy and immunoglobulin therapy. The medication section is further categorized into C5 Protein Inhibitor, monoclonal antibodies, corticosteroids, immunosuppressive agent, others.

The route of administration segment for global neuromyelitis optica spectrum disorder (NMOSD) market is segmented into oral, parenteral and others.

On the basis of end-users, the global neuromyelitis optica spectrum disorder (NMOSD) market is segmented into hospitals, homecare, specialty centres and others.

On the basis of distribution channel, the global neuromyelitis optica spectrum disorder (NMOSD) market has been bifurcated into hospital pharmacy, online pharmacy and retail pharmacy.

Global Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Country Level Analysis

Global neuromyelitis optica spectrum disorder (NMOSD) market is analyzed and market size information is provided by country, type, treatment type, route of administration, end-users and distribution channel as referenced above.

The countries covered in the global neuromyelitis optica spectrum disorder (NMOSD) market  report are U.S., Canada, Mexico in North America, Brazil, Argentina, Peru, Rest of South America, as part of South America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Hungary, Lithuania, Austria, Ireland, Norway, Poland, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Vietnam, Rest of Asia-Pacific, Saudi Arabia, in the Asia-Pacific, U.A.E, Egypt, Israel, Kuwait, South Africa, Rest of Middle East and Africa, as a part of Middle East and Africa.

North America represents the largest market share throughout the forecasted period due to the introduction of newer drugs and presence of sophisticated healthcare infrastructure which can results in effective treatment to patient suffering from the neuromyelitis optica spectrum disorder (NMOSD). Europe is lucrative market owing to the presence of global marketed as well as domestic key players in this region and growing focuses on the research and development. Asia Pacific and South America are expected to leads the market due to surge population and increase in government initiatives.

The country section of the report also provides individual market impacting factors and changes in regulations in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, disease epidemiology and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Patient Epidemiology Analysis

Global neuromyelitis optica spectrum disorder (NMOSD) market also provides you with detailed market analysis for patient analysis, prognosis and cures. Prevalence, incidence, mortality, adherence rates are some of the data variables that are available in the report. Direct or indirect impact analysis of epidemiology to market growth are analyzed to create a more robust and cohort multivariate statistical model for forecasting the market in the growth period.

Competitive Landscape and Global Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Share Analysis

global neuromyelitis optica spectrum disorder (NMOSD) market competitive landscape provides details by competitor. details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, clinical trials pipelines, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. the above data points provided are only related to the companies’ focus related to global neuromyelitis optica spectrum disorder (NMOSD) market.

Customization Available: Global Neuromyelitis Optica Spectrum Disorder (NMOSD) Market

Data Bridge Market Research is a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customized to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analyzed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.

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Neuromyelitis Optica Spectrum Disorder Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019 - 2027

Neuromyelitis Optica Spectrum Disorder Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019 – 2027

Neuromyelitis Optica Spectrum Disorder Market: Introduction

Neuromyelitis optica spectrum disorder (NMOSD) is an inflammatory disorder of central nervous system which was previously known as Devic disease or neuromyelitis optica (NMO). It is a rare debilitating and lifelong disease characterized by inflammation in spinal cord and optic nerve.

People with neuromyelitis optica spectrum disorder…

[pratikwadekar2]

Pen Needles Market Strategic Insights and key Business Influencing Factors | Major Players – DOMREX Pharma Inc., A. Menarini Diagnostics srl, Ypsomed AG, B. Braun Melsungen AG, Facet Medical Technologies.

Pen Needles Market manufacturers have developed needles to minimize pain and help to reduce skin trauma, majorly by innovating needle length and diameter, to maintain a sufficient inner lumen was the major challenge for needle manufacturers by maintaining acceptable low injection force. To maintain sufficient inner lumen manufacturer made thin needle walls, which reduced the needles robustness and increased chances of needles tip damage during administration, re-usage and during cap removal or handling.

Pen needles are used in pen devices to deliver injectable drug in diabetes and growth hormone deficiency to maintain blood sugar level. The World Health Organization and international diabetes federation has projected more than 50% rise in number of diabetes patients by 2045.

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Competitive Analysis: Asia-Pacific Pen Needles   Market

Some of the major players operating in this market are Novo Nordisk A/S, Eli Lilly and Company, Terumo Corporation, MedExel Co., Ltd, ALLISON MEDICAL, VOGT MEDICAL, Digital Medics Pty Ltd., STAT Medical Devices., DOMREX Pharma Inc., A. Menarini Diagnostics srl, Ypsomed AG, B. Braun Melsungen AG, Facet Medical Technologies, KD Medical GmbH, Haselmeier GmbH & Co. KG, pendiq GmbH, MedExel Co., Ltd, Owen Mumford Ltd., HTL-STREFA S.A., LDI, Ltd. LLC and Sanofi among others.

Key Pointers Covered in the Asia-Pacific Pen Needles Market Trends and Forecast to 2026

Asia-Pacific Pen Needles Market New Sales Volumes

Asia-Pacific Pen Needles Market Replacement Sales Volumes

Asia-Pacific Pen Needles Market Installed Base

Asia-Pacific Pen Needles Market By Brands

Asia-Pacific Pen Needles Market Size

Asia-Pacific Pen Needles Market Procedure Volumes

Asia-Pacific Pen Needles Market Product Price Analysis

Asia-Pacific Pen Needles Market Healthcare Outcomes

Asia-Pacific Pen Needles Market Cost of Care Analysis

Asia-Pacific Pen Needles Market Regulatory Framework and Changes

Asia-Pacific Pen Needles Market Prices and Reimbursement Analysis

Asia-Pacific Pen Needles Market Shares in Different Regions

Recent Developments for Asia-Pacific Pen Needles Market Competitors

Asia-Pacific Pen Needles Market Upcoming Applications

Asia-Pacific Pen Needles Market Innovators Study

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Scope of the Pen Needles   Market

Asia-Pacific Pen Needles Market By Product Type (Standard Pen Needles, Safety Pen Needles), Product Length (Medium Length, Nano Length, Long Length), Usability (Disposable, Reusable), Application (Diabetes, Growth Hormone Deficiency, Others), Therapy (Insulin, Glucagon-Like Peptide-1, Growth Hormones, Others), End User (Home Healthcare, Hospitals, Clinics, Others), Country (Japan, China, South Korea, India, Australia, Singapore, Thailand, Malaysia, Indonesia, Philippines, Rest of Asia-Pacific) - Industry Trends and Forecast to 2026

Needle manufacturers have developed needles to minimize pain and help to reduce skin trauma, majorly by innovating needle length and diameter, to maintain a sufficient inner lumen was the major challenge for needle manufacturers by maintaining acceptable low injection force. To maintain sufficient inner lumen manufacturer made thin needle walls, which reduced the needles robustness and increased chances of needles tip damage during administration, re-usage and during cap removal or handling.

Pen needles are used in pen devices to deliver injectable drug in diabetes and growth hormone deficiency to maintain blood sugar level. The World Health Organization and international diabetes federation has projected more than 50% rise in number of diabetes patients by 2045. Also, United Nation and World Health Organization has projected more than 100% rise in geriatric population in the globe, this rise will lead the global pen needles market.

Market Segmentation: Asia-Pacific Pen Needles  Market

Global Pen Needles Market is segmented into six notable segments which are based on the basis of product type, product length, usability, application, therapy and end user.

On the basis of product type, the market is segmented into safety pen needles and standard pen needles.

On the basis of product length, the market is segmented into medium length, nano length and long length.

On the basis of usability, the market is segmented into disposable and reusable.

On the basis of application, the market is segmented into diabetes, growth hormone deficiency and others.

On the basis of therapy, the market is segmented into insulin, glucagon-like peptide-1, growth hormones and others.

On the basis of end user, the market is segmented into home healthcare, hospitals, clinics and others.

 Reasons to Purchase this Report:

The segment that is expected to dominate the market as well as the segment which holds highest CAGR in the forecast period.

Regions/Countries that are expected to witness the fastest growth rates during the forecast period.

The latest developments, market shares, and strategies that are employed by the major market players.

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Key insights in the report:

Complete and distinct analysis of the market drivers and restraints

Key Market players involved in this industry

Detailed analysis of the Market Segmentation

Competitive analysis of the key players involved

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Pen Needles Market Similar Report Here:

Monoclonal Antibodies Market

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market

[azveille]

AstraZeneca spinout Viela bags $75M as FDA filing nears

AstraZeneca spinout Viela Bio has raised $75 million to take anti-CD19 antibody inebilizumab toward approval. The series B round comes 16 months after Viela broke free from AstraZeneca with six drugs and $250 million in funding.

Since then, a late-phase trial of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD) has hit its primary endpoint, teeing Viela up to file for FDA approval later in the year.

To fund the filing and pre-commercial work, Viela has brought additional investors on board. HBM Healthcare Investments led the series B with the support of new investors including Viking Global Investors, Cormorant Asset Management, Terra Magnum Capital Partners, Goldman Sachs and Barer & Son Capital. Temasek was among the existing investors to contribute to the series B.

The willingness of the investors to add to Viela’s coffers reflects the potential of inebilizumab. In the late-phase trial, patients with the rare autoimmune disease NMOSD experienced a 77% reduction in the risk of suffering an attack. NMOSD attacks can lead to blindness and paralysis.

Viela’s top priority is to bring the drug to market in NMOSD, a condition for which there are no FDA-approved treatments. The Maryland-based biotech is also interested in developing inebilizumab in other indications—AstraZeneca trialed the antibody in multiple sclerosis, systemic scleroderma and B-cell malignancies—and in advancing the other assets it picked up from its parent company.

The series B will support that expanded development program, giving Viela the financial means to start to realize the potential of the drugs it picked up from AstraZeneca. Viela is also in line to receive cash from Hansoh Pharmaceutical through a $220 million deal for the Chinese rights to inebilizumab. Hansoh talked up the potential to broaden use of the drug by pairing it with other therapies.

[kunalcmi]

NEUROMYELITIS OPTICS THERAPY MARKET ANALYSIS(2020-2027)

Neuromyelitis optica is an autoimmune disorder, in which white blood cells and antibodies attack optic nerve as well as spinal cord. Furthermore, damage of the optics nerves results in pain and loss of vision, while damage of spinal cord results in paralysis of legs or arms, loss of sensation in legs and arms, and problem in the function of bladder & bowel.

Moreover, there is no cure for neuromyelitis optica disorder, but there are therapies to treat acute attack of relapses, and to reduce symptoms. Neuromyelitis optica attacks and Neuromyelitis optica relapses are often treated with plasma exchange and corticosteroids. Moreover, initial symptoms of neuromyelitis optica such as vision loss and paralysis can be improve with high doses of intravenous corticosteroids. On the other hand, plasma exchange can be used as alternative, if the patient do not respond to intravenous corticosteroids. For long term suppression of disease, immunosuppressive agents such as azathioprine, mycophenolate mofetil, and rituximab are used to prevent the attack. Sometimes, azathioprine and mycophenolate mofetil are used with the low doses of corticosteroid to prevent the attack.

Global Neuromyelitis Optica Therapy Market Drivers

The global neuromyelitis optica therapy market is expected to witness significant growth over the forecast period, owing to increasing collaborations to launch new drugs for the treatment of neuromyelitis optica spectrum disorder. For instance, in May 2019, in China, Viela Bio, Inc. entered into strategic collaboration with Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”) to develop as well as commercialize inebilizumab drug for the treatment of autoimmune disorder such as neuromyelitis optica spectrum disorder. From the same source, in May 2019, Viela Bio had presented positive result from the pivotal study of inebilizumab in patient. Moreover, currently inebilizumab drug is not approved by the U.S Food and Drug Administartion (FDA) for sale in China and U.S.

Furthermore, rising incidence of neuromyelitis optica disorder among people is expected to propel global neuromyelitis optica therapy market growth. For instance, according to the U.S National Library of Medicine (NHS) 2019 report, prevalence of neuromyelitis optica spectrum disorders (NMOSD) is commonly observed in nations with a predominately non-Caucasian population and estimated to be high as 10 per 100,000 individuals.

Global Neuromyelitis Optica Therapy Market Restraints

However, high cost of drug such as eculizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD) yet remains one of the major restraints for global neuromyelitis Optica therapy market growth. For instance, cost of eculizumab is US$ 500,000 per patient per year, which is one of the most expensive therapies in the world for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Moreover, side effects associated with the eculizumab such as upper respiratory tract infection, back pain, anemia, nasal congestion, urinary tract infection for the treatment of neuromyelitis optica spectrum disorder (NMOSD) is another factor that is expected to hamper the global neuromyelitis optica therapy market growth.

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Global Neuromyelitis Optica Therapy Market Regional Analysis

Among regions, North America is expected to account for highest market share in the global neuromyelitis optica therapy market, owing to factors such as increasing approval of drugs for the treatment of neuromyelitis optica spectrum disorder (NMOSD) by company. For instance, in January 2019, Alexion Pharmaceuticals, Inc. received approval by the U.S Food and Drug Administartion (FDA) for eculizumab (Soliris) drug for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients.  Furthermore, from the same source, eculizumab (soliris) has reduced the need of corticosteroid and plasma exchange to prevent acute attack in patients, who are suffering from neuromyelitis optica spectrum disorder (NMOSD).

Asia Pacific is expected to exhibit highest CAGR in the global neuromyelitis optica therapy market in the forecast period due to increasing approval of drug for the treatment of neuromyelitis optica spectrum disorder (NMOSD) by company. For instance, in November 2019, Alexion Pharmaceuticals, Inc. received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Soliris (eculizumab) drug for the treatment of neuromyelitis optica spectrum disorder (NMOSD) to prevent relapse in patient.  

Furthermore, increasing number of clinical trials of drug for the treatment of neuromyelitis optica spectrum disorder (NMOSD) by company is another factor that is expected to drive the global neuromyelitis optica therapy market growth. For instance, in September 2019, Chugai Pharmaceutical Co., Ltd.  announced positive results of its phase 3 clinical study of satralizumab drug, for the treatment of neuromyelitis optica spectrum disorder (NMOSD). From the same source, in 2019, Satralizumab had shown safety profile during the clinical trial and is first investigational drug that had demonstrated benefits both as a monotherapy and add-on therapy to baseline treatment in two different clinical trials. Furthermore, from the same source, in 2019, Chugai Pharmaceutical Co., Ltd also announced that they are going to collaborate with F. Hoffmann-La Roche AG Company. The main objective of this collaboration with Hoffmann-La Roche AG company is to file global regulatory application and bring Satralizumab as a potential new treatment to patients as soon as possible.

Furthermore, in October 2019, European Medicines Agency (EMA) and U.S. FDA accepted the marketing authorization of Satralizumab drug for the treatment of neuromyelitis optica spectrum disorder in adults and adolescent patients, which was announced by Chugai Pharmaceutical Co., Ltd.

Global Neuromyelitis Optica Therapy Market Key Players

Key players operating in the global neuromyelitis optica therapy market include Alexion Pharmaceuticals Inc., Chugai Pharmaceutical Co., Ltd., Viela Bio, Inc, Hansoh Pharmaceutical Group Company Limited, AstraZeneca plc, F. Hoffmann-La Roche AG, Zydus Pharmaceuticals (USA) Inc., Alkem Laboratories, Hikma Pharmaceuticals USA Inc., and Sandoz Inc.

.

Market Taxonomy:

On the basis of drug class, the global neuromyelitis optica therapy market is segmented into:

Corticosteroids

Immunosuppressive Agents 

Azathioprine

Mycophenolate Mofetil

Rituximab

Eculizumab

Others

On the basis of distribution channel, the global neuromyelitis optica therapy market is segmented into:

Hospital Pharmacies

Retail Pharmacies

Online Pharmacies

On the basis of region, the global neuromyelitis optica therapy market is segmented into:

North America

Latin America

Europe

Middle East

Asia Pacific

Africa

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[kritikarehani]

Neuromyelitis Optica Spectrum Disorder (NMSOD) Market Research Report 2030

Neuromyelitis optica spectrum disorder (NMOSD), also known as Devic disease, is a chronic disorder of the brain and spinal cord dominated by inflammation of the optic nerve (optic neuritis) and inflammation of the spinal cord (myelitis). Classically, it was felt to be a monophasic illness, consisting of episodes of inflammation of one or both optic nerves and the spinal cord over a short period of time (days or weeks) but, after the initial episode, no recurrence. It is now recognized that most patients satisfying current criteria for NMOSD experience repeated attacks separated by periods of remission. The interval between attacks may be weeks, months or years. In its early stages, NMOSD may be confused with multiple sclerosis (MS).

DelveInsight's "Neuromyelitis Optica Spectrum Disorder (NMOSD) - Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Neuromyelitis Optica Spectrum Disorder (NMOSD), historical and forecasted epidemiology as well as the Neuromyelitis Optica Spectrum Disorder (NMOSD) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Neuromyelitis Optica Spectrum Disorder (NMOSD) market report provides current treatment practices, emerging drugs, Neuromyelitis Optica Spectrum Disorder (NMOSD) market share of the individual therapies, current and forecasted Neuromyelitis Optica Spectrum Disorder (NMOSD) market Size from 2017 to 2030 segmented by seven major markets. The Report also covers current Neuromyelitis Optica Spectrum Disorder (NMOSD) treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.

Download free sample pages: https://www.delveinsight.com/sample-request/neuromyelitis-optica-spectrum-disorder-nmosd-market

Geography Covered

· The United States

· EU5 (Germany, France, Italy, Spain, and the United Kingdom)

· Japan

Study Period: 2017-2030

Neuromyelitis Optica Spectrum Disorder (NMOSD) Disease Understanding and Treatment Algorithm

The characteristic symptoms of NMOSD are either optic neuritis or myelitis; either may occur as the first symptom. Optic neuritis is inflammation, of the optic nerve (optic neuritis) leading to pain inside the eye which rapidly is followed by loss of clear vision (acuity). Usually, only one eye is affected (unilateral) although both eyes may be involved simultaneously (bilateral). NMOSD may or may not be preceded by a prodromal upper respiratory infection.

The DelveInsight Neuromyelitis Optica Spectrum Disorder (NMOSD) market report gives a thorough understanding of the Neuromyelitis Optica Spectrum Disorder (NMOSD) by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis and treatment. 

Diagnosis 

This segment of the report covers the detailed diagnostic methods or tests for Neuromyelitis Optica Spectrum Disorder (NMOSD). 

Treatment 

It covers the details of conventional and current medical therapies available in the Neuromyelitis Optica Spectrum Disorder (NMOSD) market for the treatment of the condition. It also provides Neuromyelitis Optica Spectrum Disorder (NMOSD) treatment algorithms and guidelines in the United States, Europe, and Japan. 

Neuromyelitis Optica Spectrum Disorder (NMOSD) Epidemiology  

The Neuromyelitis Optica Spectrum Disorder (NMOSD) epidemiology division provide insights about historical and current Neuromyelitis Optica Spectrum Disorder (NMOSD) patient pool and forecasted trend for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken. 

NMOSD can affect children as young as 3 years and adults as old as 90 years. The onset of NMOSD varies from childhood to adulthood, and the average age of onset is about 40.

Key Findings

The disease epidemiology covered in the report provides historical as well as forecasted Neuromyelitis Optica Spectrum Disorder (NMOSD) epidemiology scenario in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2017 to 2030. 

Country Wise- Neuromyelitis Optica Spectrum Disorder (NMOSD) Epidemiology 

The epidemiology segment also provides the Neuromyelitis Optica Spectrum Disorder (NMOSD) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. 

Click here and get access to free sample pages of the report: https://www.delveinsight.com/sample-request/neuromyelitis-optica-spectrum-disorder-nmosd-market

Neuromyelitis Optica Spectrum Disorder (NMOSD) Drug Chapters

The dynamics of Neuromyelitis Optica Spectrum Disorder market is anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the diseases, incremental healthcare spending across the world, and the expected launch of emerging therapies during the forecast period of 2020–2030.      

Drug chapter segment of the Neuromyelitis Optica Spectrum Disorder (NMOSD) report encloses the detailed analysis of Neuromyelitis Optica Spectrum Disorder (NMOSD) marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Neuromyelitis Optica Spectrum Disorder (NMOSD) clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs 

The report provides the details of the marketed product available for Neuromyelitis Optica Spectrum Disorder (NMOSD) treatment. 

Neuromyelitis Optica Spectrum Disorder (NMOSD) Emerging Drugs 

The report provides the details of the emerging therapies under the late and mid-stage of development for Neuromyelitis Optica Spectrum Disorder (NMOSD) treatment. 

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Outlook

Neuromyelitis Optica Spectrum Disorder (NMOSD) is a heterogeneous but well-defined clinical entity, distinct from other neurologic and systemic inflammatory diseases, and treatment is poised for expansion. Treatment of NMO includes both the management of acute attacks and the prevention of future exacerbations. The goal of acute therapy is to minimize irreversible damage and accelerate recovery. Preventative therapy should lower the frequency and severity of future exacerbations.

To summarize, a better and clear understanding of the pathogenesis of Neuromyelitis Optica Spectrum Disorder (NMOSD) will significantly improve the treatment regimens and development of novel therapies. With this, several companies have started working toward the development of new therapeutic options. The NMOSD market is expected to experience a positive growth in the coming years owing to the already prescribed products along with the launch of distinctive emerging therapies in the coming years.

Furthermore, pharmaceutical companies, such as Chugai, Bio-Thera Solutions, Remegen, Harbour BioMed and others are actively working toward the development of potential therapies in order to fulfill the unmet medical needs of the currently used therapeutics.

Overall, the rise in Neuromyelitis Optica Spectrum Disorder population, increased funding by governmental bodies, and vigorous R&D activities are further expected to propel the Neuromyelitis Optica Spectrum Disorder market during the forecast period (2020–2030).

The Neuromyelitis Optica Spectrum Disorder (NMOSD) market outlook of the report helps to build the detailed comprehension of the historic, current, and forecasted Neuromyelitis Optica Spectrum Disorder (NMOSD) market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology.  

According to DelveInsight, Neuromyelitis Optica Spectrum Disorder (NMOSD) market in 7MM is expected to change in the study period 2017-2030.

Key Findings

This section includes a glimpse of the Neuromyelitis Optica Spectrum Disorder (NMOSD) market in 7MM.

The United States Market Outlook

This section provides the total Neuromyelitis Optica Spectrum Disorder (NMOSD) market size and market size by therapies in the United States.

EU-5 Countries: Market Outlook

The total Neuromyelitis Optica Spectrum Disorder (NMOSD) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom is provided in this section.

Japan Market Outlook 

The total Neuromyelitis Optica Spectrum Disorder (NMOSD) market size and market size by therapies in Japan is also mentioned. 

Neuromyelitis Optica Spectrum Disorder (NMOSD) Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the Neuromyelitis Optica Spectrum Disorder (NMOSD) market or expected to get launched in the market during the study period 2017-2030. The analysis covers Neuromyelitis Optica Spectrum Disorder (NMOSD) market uptake by drugs; patient uptake by therapies; and sales of each drug.    

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Pipeline Development Activities 

The report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Neuromyelitis Optica Spectrum Disorder (NMOSD) key players involved in developing targeted therapeutics. 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for Neuromyelitis Optica Spectrum Disorder (NMOSD) emerging therapies.

Request for sample pages: https://www.delveinsight.com/sample-request/neuromyelitis-optica-spectrum-disorder-nmosd-market

Scope of the Report

·         The report covers the descriptive overview of Neuromyelitis Optica Spectrum Disorder (NMOSD), explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies

·         Comprehensive insight has been provided into the Neuromyelitis Optica Spectrum Disorder (NMOSD) epidemiology and treatment in the 7MM

·         Additionally, an all-inclusive account of both the current and emerging therapies for Neuromyelitis Optica Spectrum Disorder (NMOSD) are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape

·         A detailed review of Neuromyelitis Optica Spectrum Disorder (NMOSD) market; historical and forecasted is included in the report, covering drug outreach in the 7MM

·         The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Neuromyelitis Optica Spectrum Disorder (NMOSD) market

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[pharmaphorumuk]

Roche trumpets data for Soliris rival in NMOSD after US, EU filings

Roche has continued to build the case for satralizumab, its experimental therapy for rare disease neuromyelitis optica spectrum disorder (NMOSD), which is heading for approval decision in the US and Europe next year.

The results of the pivotal SAkuraSky trial have now been published in the New England Journal of Medicine (NEJM) website, showing that the anti-interleukin-6 antibody cut the relapse rate in NMOSD compared to conventional immune-suppressing drugs over nearly three years of follow-up.

NMOSD is an autoimmune disease of the central nervous system that primarily affects the optic nerves and spinal cord, causing blindness, muscle weakness and paralysis. Progression of the disease is characterised by unpredictable and severe relapses that lead to nerve damage, and it can often be misdiagnosed as multiple sclerosis.

Roche is building the case for satralizumab as it approaches potential approvals of the drug and a market showdown with Alexion’s rare disease blockbuster Soliris (eculizumab), which became the first drug approved by the FDA for NMOSD in June. For now there are no approved therapies for NMOSD in Europe.

Soliris is cleared for use in patients who are anti-aquaporin-4 (AQP4) antibody positive in the US, but Roche is hoping to get a green light for all patients with NMOSD, regardless of their anti-AQP4 status.

That could make it a good first-line option if approved for marketing, as patients would not need to be screened for anti-AQP4 status.

Anti-AQP4 antibodies damage specific nerve cells called astrocytes in the optic nerve, spinal cord and brain, and appear in around two-thirds of people with NMOSD. Those with the biomarker tend to have more severe disease.

The NEJM paper indicates that eight out of 41 patients (20%) treated with satralizumab in combination with immunosuppressants had a relapse, compared to 18 out of 43 patients (43%) of those taking immunosuppressants and placebo. After 144 weeks of follow-up, 4% of patients on satralizumab were relapse-free, versus 49% of the control group.

In a subset of AQP4-positive patients, three out of 27 patients (11%) on Roche’s drug had a relapse, compared to 12 out of 28 (43%) in the placebo arm.

NMOSD is thought to affect between 4,000 to 8,000 patients in the US, and patients are typically treated with immunosuppressants – sometimes alongside corticosteroids – that have a high risk of side effects.

Other potential treatments for NMOSD are also coming through the industry pipeline, including Viela Bio’s anti-CD19 antibody inebilizumab, which completed a first phase 3 trial earlier this year that showed a 77% reduction in relapses after 28 weeks in AQP4-positive patients.

The post Roche trumpets data for Soliris rival in NMOSD after US, EU filings appeared first on .

from https://pharmaphorum.com/news/roche-trumpets-data-for-soliris-rival-in-nmosd-after-us-eu-filings/

[pharmaphorumuk]

Roche preps filings for satralizumab in rare disease NMOSD

Roche is two for two in its phase 3 trials programme for satralizumab in the rare disease neuromyelitis optica spectrum disorder (NMOSD), setting up regulatory filings.

The interleukin-6-targeting antibody reduced the risk of relapse by 55% compared to placebo in the SAkuraStar trial reported at the ECTRIMS conference in Stockholm this week, backing up the results of the SAkuraSky study reported last year as an add-on therapy .

NMOSD is an autoimmune disease of the central nervous system characterised by unpredictable relapses causing potentially irreversible consequences, such as blindness and paralysis.

Satralizumab performed even better in patients with a specific biomarker – anti-aquaporin-4 (AQP4) antibody – with a 74% reduction in relapses risk compared to placebo.  AQP4 antibodies target and damage specific nerve cells (astrocytes) in optic nerve, spinal cord and brain.

For years there was no specifically approved treatment for NMOSD, is thought to affect around 4,000 to 8,000 patients in the US, with patients treated with immunosuppressants – sometimes alongside corticosteroids – that have a high risk of side effects.

That changed very recently when Alexion got a green light for its complement C5 inhibitor Soliris (eculizumab) in adults with AQP4-positive NMOSD, which in trials reduced the risk of relapse by around 65% after 48 weeks.

Other potential treatments for NMOSD are also coming through the industry pipeline, including Viela Bio’s anti-CD19 antibody inebilizumab, which completed a first phase 3 trial earlier this year that showed a 77% reduction in relapses after 28 weeks in AQP4-positive patients.

Satralizumab seems to have matched the efficacy of these other drugs, which all promise to improve on the safety of treatment, whilst also having activity in all-comer NMOSD patients who don’t have the AQP4 biomarker. That could make it a good first-line option if approved for marketing, as an estimated one-third of patients with NMOSD are AQP4-negative.

“The positive results from the pivotal SAkuraStar and SAkuraSky studies support the hypothesis that IL-6 plays a key role in this devastating disease that can take away people’s independence,” said Sandra Horning, Roche’s soon-to-depart chief medical officer.

“We are encouraged by these results and look forward to working with regulators over the coming months to bring satralizumab to people living with NMOSD as soon as possible,” she added.

The post Roche preps filings for satralizumab in rare disease NMOSD appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/roche-preps-filings-for-satralizumab-in-rare-disease-nmosd/

[pharmaphorumuk]

Alexion’s biosimilar-blocking EU patent play for Soliris fails

The European Patent Office has blocked an attempt by Alexion to extend the patent protection for its blockbuster drug Soliris, setting up biosimilar competition from 2022.

The EPO delivered its verdict late last week but Alexion’s share price remained unscathed by the news, suggesting investors are confident that the company will be able to migrate revenues to its follow-up drug Ultomiris by that date.

In a brief Securities & Exchange Commission filing, Alexion said the EPO had rejected its attempt to extend two patents for Soliris (eculizumab) and it is considering an appeal.

It’s also facing a patent challenge to Soliris in the US from Amgen, which is developing a biosimilar version of the drug called ABP 959 and has petitioned the US Patent and Trademark Office (USPTO) to review Alexion’s intellectual property on the drug. It made the move after Alexion won an extension on its US patent life until 2027.

Soliris – a complement C5 inhibitor used to treat several rare diseases including paroxysmal nocturnal hemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS) – achieved sales of $1.94 billion in the first six months of the year, accounting for more than 80% of the biotech’s total sales in that period.

Alexion is expecting Soliris to make around $4.1 billion in sales this year, a rise of around $500 million on its 2018 tally, thanks to newer indications such as generalised myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD).

Successor Ultomiris (ravulizumab) works at least as well as Soliris according to clinical trials, but can be administered less frequently. It’s given intravenously every eight weeks rather than every two weeks with Soliris, cutting the number of doses needed from 26 to six per year.

So far take-up of the new drug has been modest, with sales of just under $80 million in the first half of the year following its first approval in PNH and launch in the US in January. Clarivate Analytics has predicted it will approach $2 billion in sales by 2023.

Analyst Phil Nadeau of Cowen said that Alexion’s C5 inhibitor franchise is “more defensible than most investors give it credit for”, suggesting in a research note that most patients will have switched to Ultomiris by the time biosimilars arrive on the market in 2022/2023.

The post Alexion’s biosimilar-blocking EU patent play for Soliris fails appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/alexions-biosimilar-blocking-eu-patent-play-for-soliris-fails/