#Nexletol

[actionsportsinc]

Excited to announce a new sponsor for #rfkracing and #bradkeselowski !!! #Esperion is the parent company, its products are #NEXLIZET and #NEXLETOL. NEXLIZET will be featured on Brad’s car, while NEXLETOL will be the feature on Chris’ car, when they are the primary. In total its six races including the #Daytona500 for Brad, with three races each across both cars. (at Roush Fenway Racing) https://www.instagram.com/p/CnSwVRRveD8/?igshid=NGJjMDIxMWI=

[regenhealthsolutions]

Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients

A nonstatin therapy approved almost 3 years ago to treat low-density lipoprotein (LDL) cholesterol also cuts the risk of major cardiovascular events, especially heart attacks, according to data presented. Bempedoic acid, approved in February 2020 as Nexletol (Esperion), reduced by 13% the risk of a 4-part composite end point of major adverse cardiovascular events (MACE), according to results…

[xtruss]

Can't Take Statins? New Pill Cuts Cholesterol, Heart Attacks

— By Lauren Neergaard | Associated Press | March 4, 2023

This undated photo provided by Esperion Therapeutics Inc. shows the cholesterol-lowering drug Nexletol. In a major study released Saturday, March 4, 2023, Nexletol reduced the risk of heart attacks and other health problems in people who can't take drugs called statins, the main cholesterol-lowering treatment. (Esperion Therapeutics Inc. via AP, File)

Drugs Known As Statins are the first-choice treatment for high cholesterol but millions of people who can’t or won’t take those pills because of side effects may have another option.

In a major study, a different kind of cholesterol-lowering drug named Nexletol reduced the risk of heart attacks and some other cardiovascular problems in people who can’t tolerate statins, researchers reported Saturday.

Doctors already prescribe the drug, known chemically as bempedoic acid, to be used together with a statin to help certain high-risk patients further lower their cholesterol. The new study tested Nexletol without the statin combination -- and offers the first evidence that it also reduces the risk of cholesterol-caused health problems.

Statins remain “the cornerstone of cholesterol-lowering therapies,” stressed Dr. Steven Nissen of the Cleveland Clinic, who led the study.

But people who can’t take those proven pills “are very needy patients, they’re extremely difficult to treat,” he said. This option “will have a huge impact on public health.”

Too much so-called LDL or “bad” cholesterol can clog arteries and lead to heart attacks and strokes. Statin pills like Lipitor and Crestor – or their cheap generic equivalents – are the mainstay for lowering LDL cholesterol and preventing heart disease or treating those who already have it. They work by blocking some of the liver’s cholesterol production.

But some people suffer serious muscle pain from statins. While it’s not clear exactly how often that occurs, by some estimates 10% of people who’d otherwise qualify for the pills can’t or won’t take them. They have limited options, including pricey cholesterol-lowering shots and another kind of pill sold as Zetia.

Nexletol also blocks cholesterol production in the liver but in a different way than statins and without that muscle side effect.

The new five-year study tracked nearly 14,000 people who were unable to tolerate more than a very low dose of a statin. Half got daily Nexletol and half a dummy pill.

The main finding: Nexletol-treated patients had a 13% lower risk of a group of major cardiac problems. Then researchers teased apart those different conditions and found a 23% reduced risk of a heart attack, the biggest impact. The drug also cut by 19% procedures to unclog arteries. There wasn’t a difference in deaths, which researchers couldn’t explain but said might require longer to detect.

The data was published in the New England Journal of Medicine and presented Saturday at a meeting of the American College of Cardiology. The study was funded by Nexletol maker Esperion Therapeutics.

The results are “compelling,” Dr. John H. Alexander of Duke University, who wasn’t involved with the study, wrote in the journal. They “will and should” spur use of the drug by patients unwilling or unable to take statins.

“It is premature, however, to consider bempedoic acid as an alternative to statins,” he cautioned. “Given the overwhelming evidence of the vascular benefits,” statins remain the top choice for most patients.

[best2daynews]

Can't take statins? New pill cuts cholesterol, heart attacks - news today

Drugs known as statins are the first-choice treatment for high cholesterol but millions of people who can’t or won’t take those pills because of side effects may have another option. In a major study, a different kind of cholesterol-lowering drug named Nexletol reduced the risk of heart attacks and some other cardiovascular problems in people who can’t tolerate statins, researchers reported…

[usasportsworld]

Esperion Therapeutics sponsoring RFK Racing; includes primary races with Brad Keselowski and Chris Buescher – Jayski's NASCAR Silly Season Site

Esperion Therapeutics sponsoring RFK Racing; includes primary races with Brad Keselowski and Chris Buescher – Jayski’s NASCAR Silly Season Site

NEXLETOL will be featured on Chris Buescher’s #17 Ford at Las Vegas in March and both Martinsville races. Image from RFK Racing. RFK Racing has announced that Esperion Therapeutics, a Michigan-based pharmaceutical company, has partnered with the team for a multi-year agreement pursuant to which Esperion will promote two cholesterol lowering treatments – NEXLIZET (bempedoic acid and ezetimibe)…

[prensard]

Nuevo e innovador medicamento contra el colesterol malo es aprobado por la FDA La Administración de Alimentos y Medicamentos (FDA), aprobó un nuevo medicamento para combatir el colesterol malo (LDL).

[jovialfoxnight]

Esperion anuncia dos datos de NEXLETOL® (ácido bempedoico)

Esperion anuncia dos datos de NEXLETOL® (ácido bempedoico)

ANN ARBOR, Michigan, 3 de abril de 2022 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) presentó hoy dos nuevos análisis de su programa de desarrollo clínico de ácido bempedoico (NEXLETOL®) en la Exposición y Sesión Científica Anual 71 del Colegio Americano de Cardiología (ACC.22). El primer análisis titulado “Seguridad y eficacia del ácido bempedoico en pacientes con insuficiencia renal” fue…

[your-dietician]

Is High Cholesterol Genetic?

New Post has been published on https://depression-md.com/is-high-cholesterol-genetic/

Is High Cholesterol Genetic?

There are many causes of high cholesterol—everything from diet, activity levels, and medications—but among the more concerning of these is genetics. Approximately one in 250 people have an inherited form of this condition called familial hypercholesterolemia (FH), meaning they’re genetically predisposed to develop unhealthy high levels.

FH specifically refers to excessively elevated levels of low-density lipoprotein (LDL) or “bad” cholesterol due to a genetic mutation, and what’s alarming is that it’s associated with earlier onset of coronary artery disease (CAD), increasing the risk of heart attack and stroke. Making this issue even more critical, only about 10% to 20% of those with the condition know they have it.

It’s important to have a sense of what FH is, how it presents, and how it can be managed.

x-reflexnaja / Getty Images

What Is Familial Hypercholesterolemia?

As mentioned, FH arises due to an inherited mutation of a specific gene; this hinders the body’s ability to manufacture receptors to clear LDL from your blood. There are actually two types of FH, depending on whether the genetic abnormality was inherited from one or both parents. Here’s a quick breakdown:

Heterozygous FH: This more common type of FH occurs when one parent carries the faulty gene, and the other doesn’t. In these cases, people display high LDL from birth on, with levels climbing to especially dangerous levels in adults.

Homozygous FH: When both parents carry the faulty gene, this type of FH arises. It causes even more severe LDL levels from birth on, as no LDL receptors are present. As such, homozygous FH is associated with significantly earlier onset of serious heart problems and other issues.

If high cholesterol runs in your family, you should have your levels checked more regularly.

Causes of High Cholesterol

In addition to genetics, high cholesterol arises due to several factors:

Diet: Certain foods, especially those high in trans and saturated fats (as in fatty meats, dairy, and processed foods), elevate cholesterol levels.

Level of activity: Those who do not get enough exercise or physical activity are at risk for high cholesterol.

Weight status: Being overweight (a body mass index (BMI) of 25 to 29.9) or obese (BMI greater than 30) are significant risk factors for high cholesterol.

Lifestyle factors: Smoking tobacco and consuming alcohol are directly linked with higher levels of cholesterol.

Medications: Certain medications, including certain steroids, antiviral medications, beta-blockers, immunosuppressants, and diuretics, among others, can cause levels to rise.

Other diseases: Higher cholesterol can also be caused by other diseases or health conditions, including chronic kidney disease, human immunodeficiency virus (HIV/AIDS), hepatitis C, and pregnancy, among others.

Signs and Symptoms

So how can you tell if you have high cholesterol? And how can you tell if high levels are due to FH? A big issue, unfortunately, is that you often can’t without testing. High cholesterol is often asymptomatic, which is a major reason why it often goes undetected. Over time, it can lead to restrictions or blockages of coronary and other arteries in the body, respectively. This can lead to:

Angina (chest pains or discomfort)

Fatigue,

Irregular heartbeat

Shortness of breath

Cramping or pain in the limbs, especially when walking

Slurred speech

Drooping on one side of the face

Weakness or numbness in the limbs

There are also a couple symptoms of high cholesterol that are particularly associated with FH:

Xanthoma: Excess levels of LDL cholesterol can cause nodules to form in clusters around the hands, elbows, feet, and other parts of the body. In children and infants particularly, these are signs of FH.

Achilles tendon xanthoma: When a xanthoma develops in the Achilles tendon on the back of the foot, it can cause serious damage. Tendonitis, an inflammation of the tendon, as well as rupture can occur.

Corneal arcus: Cholesterol deposits can also form around the cornea, the transparent portion that covers the front of the eye. This causes gray, white, or yellowish rings to form around both corneas.

Complications

The real danger of FH is that it can lead to a host of very serious conditions. When you have high cholesterol—especially high levels of LDL—a plaque can form in the arteries. Over time, this build-up causes them to narrow, harden, and stiffen—a condition called atherosclerosis. This reduces blood flow, which can cause:

Heart attack: If FH is untreated, the risk of fatal or nonfatal heart attack rises 50% in men younger than 50, and 30% in women under 60. This dangerous condition is often the result of coronary artery disease (CAD).      

Heart disease: Aside from CAD, heart failure can also occur, which is when insufficient amounts of blood reach the rest of the body. In addition, arrhythmia—irregular heartbeat—can occur.  

Stroke: Interruptions in blood flow to the brain associated with high cholesterol greatly increase the chance of developing a stroke, in which clots cause brain cells to die. This potentially fatal condition severely impacts neurological function.  

Peripheral vascular diseases: Interrupted blood flow in the limbs causes peripheral artery disease (PAD), leading to numbing, cramping, and pain when walking. These conditions can also affect skin and tissues in the limbs to heal.

Causes and Risk Factors

FH arises when genes associated with producing receptors that clear LDL cholesterol from the bloodstreams are mutated. Faulty copies of four genes—LDLR, LDLRAP1, APOB, or PCSK9—can cause the condition, with most arising due to LDLR mutation. Your chances of developing FH are 50% if one parent has it, and 100% if both do.

Heterogenous FH, by far the most common type, arises when a faulty gene from an affected parent is paired with a healthy counterpart from the other. Only about half of the receptors that clear out LDL are present in these cases. When both parents carry the variant, homogenous FH arises, in which these receptors are entirely absent.

Globally, FH is one of the most common genetic disorders seen; however, exact estimates of prevalence are difficult because the condition often goes undetected. That said, certain populations have been found to have higher rates of inherited high cholesterol:

Lebanese Christians

Afrikaners in South Africa

French Canadians

Ashkenazi Jews

Diagnosis

Diagnosis of FH involves a combination of physical examination of symptoms, and, most conclusively, lab tests. Critical among the latter is the lipoprotein profile, sometime called a lipid panel, which measures levels of LDL, HDL (good cholesterol), and triglyceride (another type), while also providing a total score.

Doctors suspect FH in the following cases:

High total cholesterol: In children, scores above 250 milligrams/deciliter (mg/dL) prompt concern, with this figure rising to 300 mg/dL in adults.

High LDL: Levels of bad (LDL) cholesterol above 200 mg/dL in adults, and 150 mg/dL in children, can be signs of FH.

Physical symptoms: Those with xanthoma, corneal arcus, and Achilles tendon xanthoma will be suspected for FH.

Family history: Having an immediate relative with high cholesterol or early heart disease (onset younger than 55 for a father or brother, and 65 for a sister or mother) will warrant additional examination.   

In suspected cases, while several sets of criteria (such as MEDPED) are effective at catching cases, only genetic testing can conclusively determine the presence of FH. They will show which specific genes are abnormal, with mutations in LDLR, APOB, and PCSK9 genes seen in 70% to 80% of these cases.

Treatment

Because of its nature, taking on FH can be difficult, and it often involves a multifaceted approach. Medications can certainly take on this condition, but lifestyle changes can help a great deal. The key is timely detection and prompt management.

Medications

Diagnosis of FH usually means being put on prescription medication, with the primary goal of lower LDL cholesterol levels. For high cholesterol, you most often see the following classes of drugs prescribed:

Statins reduce the amount of cholesterol produced by the liver and may also be taken for heart attack and stroke. Lipitor (atorvastatin), Lescol (fluvastatin), and Mevacor (lovastatin) are among the most commonly prescribed of these.   

Bile acid sequestrants affect liver function, hindering its digestive function, which burns up cholesterol. Also called “resins,” this class of drug includes Questran (cholestyramine) and Colestid (colestipol), among others.

Fibrates lower triglyceride levels and raise HDL to reduce the impact of LDL cholesterol. For FH, you may be prescribed fenofibrate, which is sold as Antara, Tricor, or Fenoglide.

Other classes of drugs often indicated are PCSK9 inhibitors (alirocumab and evolocumab), selective cholesterol absorption inhibitors [Zetia (ezemtimibe); ACL inhibitors (Nexletol (bempedoic acid)], omega 3 fatty acids, and niacin.   

LDL Apheresis

In difficult cases of FH, especially homogenous FH or heterogenous FH that’s resistant to drug treatment, a nonsurgical procedure called LDL apheresis may be attempted. The plasma of the blood is separated from the rest and run through a machine that removes the LDL. This is then combined with the rest.

Lifestyle Changes

While on their own, lifestyle changes may not be enough to reverse high cholesterol in FH, they can have a huge impact on outcomes. A recommended approach might include:

Steering clear of tobacco: Among the many negative aspects of smoking is elevated cholesterol levels; quitting can help bring them down.   

Adjusting diet: Steer clear of foods high in trans or saturated fats, like red meat or fried foods. Cut out sugars, whole milk products, and emphasize heart-healthy foods: fruits and vegetables, fish, poultry, and whole grains.

Getting exercise: Being more active can certainly help bring down cholesterol levels. If you aren’t active, aim for about 150 minutes a week, or about 30 minutes a day, five of the seven days. Even low impact activities like brisk walks or cycling can help.

Losing weight: If you’re overweight or obese, you’ll want to see about means of losing weight. Even modest losses of 10% of body weight can positively impact cholesterol levels. Talk to your doctor about how to safely and sustainability achieve your target weight.

Maintaining emotional health: Stress and anger can also cause cholesterol levels to climb. Adopting means to take on these negative emotions, like meditation or yoga, can also help.

Managing other conditions: Diabetes mellitus, which affects blood sugar, is another cause of high cholesterol, as is hypertension (high blood pressure). Getting the right treatment for these conditions will also help lower your cholesterol.      

Prognosis

If caught early and treated appropriately, most cases of heterogenous FH can be effectively managed. This is why it’s important to carefully follow doctor’s orders about lifestyle changes and medications. Notably, such care will significantly reduce the chance of severe complications, like heart attack.

The outlook is considerably worse for homogenous FH. This form is notoriously resistant to treatment, and it’s associated with onset of early heart attack (under 55 in men, and under 65 in women). Careful monitoring and more aggressive treatment is necessary in these cases.

FAQs

What is genetic high cholesterol?

Clinically referred to as familial hypercholesteremia (FH), genetic high cholesterol is high cholesterol that runs in families. Specifically, this causes elevated levels of LDL cholesterol (the “bad” kind), which is linked with an increased risk of developing coronary artery disease.

As an autosomal dominant disorder, parents with FH have a 50% chance of passing it to their children. The most common type is heterozygous FH (HeFH), which is when only one of your parents is carrying the gene variant that causes the condition. When both parents have it, in cases of homozygous FH (HoFH), two faulty variants are inherited. The latter is the more severe form.

How do you know if your high cholesterol is genetic?

If you’re found to have high cholesterol, your doctor will ask whether there’s any family history of the condition. If there is, this can be a first clue that your case is FH. The only way to conclusively know, however, is through genetic testing and counseling. Doctors look for mutations of the genes LDLR, LDLRAP1, APOB, or PCSK9, which help regulate cholesterol levels.

However, in about 20% to 30% of FH cases, standard genetic testing is unable to find the faulty gene. As such, negative results do not necessarily rule out a diagnosis.

What percentage of high cholesterol is genetic?

While about one in three Americans has high cholesterol, only about one in 200 adults has FH. Counting children, it affects an estimated 1.3 million Americans; however, about 90% of cases are undiagnosed. A vast majority of high cholesterol cases are due to other factors, such as diet and lifestyle.

Can you lower cholesterol if it’s genetic?

While high cholesterol can be tougher to take on if it’s due to FH, it can be managed. Making lifestyle changes such as adopting a cholesterol-lowering diet and increasing physical activity is the first step in lowering cholesterol.

Since FH cases are often resistant to these approaches, taking cholesterol-lowering drugs, such as statins or bile acid sequestrants, can further manage the condition. In severe cases of HoFH, pharmaceutical therapies may be supplemented with apheresis or liver transplant to normalize levels.

A Word From Verywell

While inherited high cholesterol can be difficult and dangerous, it’s important not to forget that it can be handled through a combination of medicine and lifestyle changes. Managed proactively and caught early, outcomes improve dramatically.

If you have any concerns about your cholesterol, or you know that FH runs in your family, don’t hesitate in talking to your doctor about getting tested. Certainly seek help if you feel any symptoms in your chest, limbs, or head.

A confirmed case is not the end of the world; it’s merely the beginning of the road to recovery. So long as you’re engaged in that process—and have help along the way—you’ll be able to take control of your cholesterol levels.    

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[pharmaphorumuk]

NICE backs AZ’s Calquence for new use in leukaemia

AstraZeneca’s BTK inhibitor Calquence has become the first targeted oral therapy to be backed by NICE for NHS England patients with chronic lymphocytic leukaemia (CLL) who can’t be treated with first-line chemotherapy.

The new draft recommendation from the cost-effectiveness watchdog comes after it backed use of the drug last December in untreated high-risk CLL – i.e. those with 17p deletion or TP53 mutation – or patients with the blood cancer who have previously been treated with other drugs.

At the time, NICE said it couldn’t support use of Calquence for untreated, non-high risk CLL patients unsuitable for treatment with chemo, although AZ pledged to provide additional information in this group.

Now it has changed its mind, Calquence will be available to treat around 2,395 eligible patients by the NHS every year, according to AZ.

Calquence was approved in CLL by the EMA last November in both previously untreated and relapsed or refractory patients as a monotherapy or in combination with Roche’s Gazyvaro (obinutuzumab) in CLL.

NICE’s guidance says that it “has not made recommendations on the use of acalabrutinib with obinutuzumab because the company did not submit any data for this combination.”

AZ has agreed a confidential discount to Calquence’s $5,000-plus monthly price as part of its negotiations with NICE on securing NHS coverage of the drug in CLL, which is the most common type of blood cancer in adults in the UK.

People with untreated CLL without a 17p deletion or TP53 mutation usually get treated with fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR), and if those are unsuitable the go-to therapy is Gazyvaro with chlorambucil.

Clinical trial data suggests CLL takes longer to progress when treated with Calquence than with Gazyvaro/chlorambucil, says NICE, although it says the survival benefit is uncertain.

Calquence can also be given as an outpatient while Gazyvaro-based therapy requires intravenous administration in hospital, making at a good option for older and frail patients, according to AZ.

“This NICE recommendation has the potential to improve disease outcomes for thousands of patients with CLL in the UK,” said Anna Schuh, associate professor and honorary consultant haematologist at the University of Oxford.

“There has been a significant unmet need for effective, targeted treatments that are well tolerated and that do not require multiple hospital visits, especially for patients in need of treatment for the first time,” she added.

First approved for mantle cell lymphoma (MCL) in 2017, Calquence sales have rocketed since its approval for CLL towards the end of 2019, rising to $522 million in 2020 from $164 million in the prior year.

Daiichi Sankyo gets okay for cholesterol drugs

NICE meanwhile has also given a green light to two orally-active drugs for high cholesterol – Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) – from Daiichi Sankyo.

The two drugs are the first new oral treatments for cholesterol lowering to be backed for NHS use in more than a decade, and will be an option for up to 100,000 eligible patients, according to the company.

NICE’s final appraisal document for the two drugs recommends their use in treating primary hypercholesterolaemia or mixed dyslipidaemia, but only in people who can’t take statins. The decision is at odds with the situation in Scotland, where Nilemdo was turned down in December.

“Until now, patients with hypercholesterolaemia who cannot tolerate statins have had limited treatment options,” commented Professor Kausik Ray, professor of public health and honorary consultant cardiologist at Imperial College London.

“Availability of treatments such as these is essential in tackling cardiovascular disease, the leading cause of death in the UK.”

Originally developed by US biopharma company Esperion, Nilemdo was approved by the EMA in April 2020, a couple of months after it got a green light from the US FDA as Nexletol.

Analysts have previously suggested that Nexletol/Nilemdo may become a blockbuster product, perhaps bringing in as much as $3 billion a year at peak.

The post NICE backs AZ’s Calquence for new use in leukaemia appeared first on .

from https://pharmaphorum.com/news/nice-backs-azs-calquence-for-new-use-in-leukaemia/

[ericvick]

Looking to decarbonize the metal industry, Bill Gates-backed Boston Metal raises $50 million

TipRanks

3 Stocks Trading at Rock-Bottom Prices; Analysts Say ‘Buy’

A new year, a new addition to the stock portfolio – what can make more sense than that? The right time to buy, of course, is when stocks are priced at the bottom. Buying low and selling high may be a bit hackneyed, but it’s true, and truth has staying power.But the markets are up. The NASDAQ rose 43% in 2020, and the S&P 500 showed a gain of 16%. With a market environment like that, finding stocks that are caught in the doldrums is harder than it looks. That’s where the Wall Street pros can lend a hand.We used TipRanks’ database to pinpoint three stocks that fit a profile: a share price that has dropped over 30% in the last 12 months, but with at least double-digit upside potential, according to analysts. Not to mention each has earned a Moderate or Strong Buy consensus rating.Esperion (ESPR)We will start with Esperion, a company that specializes in therapies for the treatment of elevated low-density lipoprotein cholesterol levels – a major factor contributing to heart disease. The company’s main product, bempedoic acid, is now available in tablet form under the brand names Nexletol and Nexlizet.In February 2020, both Nexletol and Nexlizet were approved as oral treatments to lower LDL-C. Bempedoic acid remains in clinical trials of its efficacy in risk reduction for cardiovascular disease. The trial, called CLEAR Outcomes, is a large-scale, long-term study, tracking more than 14,000 patients with top-line data expected in the second half of 2022. The study covers 1,400 locations in 32 countries around the world.Esperion shares peaked last February, after the FDA approvals, but since then, the stock has declined. Shares are down 65% since their peak. Along with the drop in share value, the company showed a fall in revenue from Q2 to Q3, with the top line collapsing from $212 million to $3.8 million. Since the Q3 report, Esperion announced pricing on a $250 million offer of senior subordinated notes, at 4%, due in 2025. The offering gives the company a boost in available capital for further work on its development pipeline and its marketing efforts for bempedoic acid.Chad Messer, covering ESPR for Needham, sees the note offering as a net positive for Esperion. “We believe this cash position will be sufficient to support Esperion through 2021 and to profitability in 2022… We believe this financing should help put to rest concerns regarding Esperion’s balance sheet. Despite a challenging launch for NEXLETOL and NEXLIZET, product growth has continued in 3Q against the backdrop of a contracting LDL-C market. This growth trajectory suggests potential for a rapid acceleration when conditions improve,” Messer wrote.To this end, Messer rates ESPR shares a Strong Buy, and his price target, at $158, suggests the stock has room for huge growth this year – up to 481% from current levels. (To watch Messer’s track record, click here)Overall, Esperion has 6 recent reviews on record, with a breakdown of 5 Buys and 1 Hold to give the stock a Strong Buy rating from the analyst consensus. The shares, trading at $27.16, have an average price target of $63.33, implying a one-year upside of 133%. (See ESPR stock analysis on TipRanks)Intercept Pharma (ICPT)Liver disease is a serious health threat, and Intercept Pharma is focused on developing treatments for some of the more dangerous chronic liver conditions, including nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). Intercept has a research pipeline based on FXR, a regulator of bile acid pathways in the hepatic system.FXR’s action affects not just the bile acid metabolism, but also the glucose and lipid metabolisms, and inflammation and fibrosis around the liver. The lead compound, obeticholic acid (OCA), is an analog of the bile acid CDCA, and as such can take a role in the FXR pathways and receptors implicated in chronic liver disease. Treating liver disease through the FXR biology has direct applications for PBC, and is showing promise treating complications from NASH.ICPT shares dropped sharply last summer, when the FDA rejected the company’s application to approve OCA for treatment of NASH-related liver fibrosis. This delays the drug’s potential entry to a lucrative market; there is no current treatment for NASH, and the first drug to win approval will have the lead in reaching a market estimated at $2 billion to $5 billion in potential annual sales. The effect on the stock is still felt, and ICPT remains at its 52-week low point.In reaction, in December of 2020, Intercept announced major changes in top-level management, as CEO and President Mark Pruzanski announced he’s stepping down effective January 1 of this year. He is succeeded by Jerome Durso, formerly the company’s COO, who will also take a post on the Board of Directors. Pruzanski will remain as an advisor, and will hold a director’s position on the company’s Board.Piper Sandler analyst Yasmeen Rahimi takes a deep dive into Intercept’s continuing efforts to expand applications of OCA and to resubmits its New Drug Application to the FDA. She sees the leadership transition as part of these efforts, and writes, “[We] believe that Dr. Pruzanski’s dedication to transform the liver space is still strong, and that he will continue to guide ICPT’s progress as an advisor and Board member. Additionally, we have had the pleasure of working closely with Jerry Durso and believe that he will transform the company and lead ICPT’s success in growing the PBC market and the path to potential approval and commercial launch of OCA in NASH.”Rahimi takes a long-term bullish stance on ICPT, giving the stock an Overweight (i.e. Buy) rating and an $82 price target. This figure indicates an impressive 220% upside for the next 12 months. (To watch Rahimi’s track record, click here)Wall Street is somewhat more divided on the drug maker. ICPT’s Moderate Buy consensus rating is based on 17 reviews, including 8 Buys and 9 Holds. Shares are priced at $25.82, and the average price target of $59.19 suggests an upside potential of 132% for the next 12 months. (See ICPT stock analysis on TipRanks)Gilead Sciences (GILD)Gilead has had a year like a firework – fast up and fast down. The gains came in 1H20, when it appeared that the company’s antiviral drug remdesivir would become a prime treatment for COVID-19. By November, however, even though remdesivir had been approved, the World Health Organization (WHO) was recommending against its use, and the COVID vaccines now on the market have made remdesivir irrelevant to the pandemic.This was only one of Gilead’s recent headwinds. The company has been working, in conjunction with Galapagos (GLPG), on development of filgotinib as a treatment for rheumatoid arthritis. While the drug received EU and Japanese approval in September 2020, the FDA has withheld approval and Gilead announced in December that it was suspending US development efforts on the drug.Even so, Gilead retains a diverse and active research pipeline, with over 70 research candidates at varying stages of the development and approval process for a wide range of diseases and conditions, including HIV/AIDS, inflammatory & respiratory diseases, cardiovascular disease, and hematology/oncology.On a positive note, Gilead posted Q3 earnings above estimates, with the top line revenue, of $6.58 billion, beating the forecast by 6% and growing 17% year-over-year. The company updated its full-year 2020 guidance on product sales from $23 billion to $23.5 billion.Among the bulls is Oppenheimer analyst Hartaj Singh, who gives GILD shares an Outperform (i.e. Buy) rating and $100 price target. Investors stand to pocket a 69% gain should the analyst’s thesis play out. (To watch Singh’s track record, click here)Backing his stance, Singh writes, “We continue to believe in our thesis of (1) a dependable remdesivir/other medicines business against SARS-CoV flares, (2) a base business (HIV/oncology/HCV) growing low-single digits over the next couple of years, (3) operating leverage providing greater earnings growth, and (4) a 3-4% dividend yield.” What does the rest of the Street think? Looking at the consensus breakdown, opinions from other analysts are more spread out. 10 Buys, 12 Holds and 1 Sell add up to a Moderate Buy consensus. In addition, the $73.94 average price target indicates 25% upside potential from current levels. (See GILD stock analysis on TipRanks)To find good ideas for beaten-down stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

[awesomearabmedicalpro]

الكولسترول المخدرات الجديدة التي وافقت عليها ادارة الاغذية والعقاقير

الاثنين 24 فبراير ، 2020 (HealthDay News) – تمت الموافقة على نوع جديد من أدوية خفض الكوليسترول التي تعمل بشكل مختلف عن العقاقير المخفضة للكوليسترول من قبل إدارة الغذاء والدواء الأمريكية.

ستوفر Nexletol من Esperion Therapeutics Inc. بديلاً للأشخاص الذين لا يستطيعون تحمل أو لا يستجيبون تمامًا لعقاقير الاستاتين مثل Lipitor و Crestor ، وكالة انباء ذكرت.

Nexletol هو حبوب منع الحمل اليومية المعتمدة للأشخاص الذين لديهم استعداد وراثي لارتفاع الكوليسترول في الدم ومرضى أمراض القلب الذين يحتاجون إلى مزيد من خفض الكوليسترول السيئ. يجب تناول الدواء بأعلى جرعة يمكن للمرضى تحملها واستخدامها مع نظام غذائي صحي ، وفقًا لإدارة الأغذية والعقاقير.

وقال الدكتور كريستي بالانتاين ، رئيس قسم أمراض القلب في كلية بايلور للطب: "هذا بديل جميل" للستاتين ، لكن الستاتين سيظل الخيار الأول. AP. يتشاور مع Esperion وساعد في اختبار Nexletol.

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FDA Approves New Cholesterol Drug

Nexletol is a daily pill approved for people with a genetic predisposition for high cholesterol and for heart disease patients who need to further reduce their bad cholesterol.

FDA Approves New Cholesterol Drug published first on https://wittooth.tumblr.com/

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U.S. approves new type of cholesterol drug, Nexletol U.S. approves new type of cholesterol drug, NexletolRead More

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Global Hyperlipidemia Drug Market Size, Share & Forecast to 2025

The global hyperlipidemia drug market is estimated to witness significant growth during the forecast period. The demand for a statin to manage cholesterol is driving the market growth across the globe. This drug supports lowering cholesterol, hence reduce the chances of cardiovascular diseases, stroke, and diabetes. Statins are used to manage the plaque on blood vessels and reduce the risk of blood clots. There are various statins options are available in the market for lowering cholesterol levels. Some of the statins used in the US include Atorvastatin (Lipitor), Lovastatin (Altoprev), Pitavastatin (Livalo, Zypitamag), Pravastatin (Pravachol), Rosuvastatin (Crestor, Ezallor), and Simvastatin (Zocor).

Get Free Sample Copy @ https://www.omrglobal.com/request-sample/hyperlipidemia-drug-market

Further, according to the American Heart Association (AHA), historical data shows 79.8% of adults who were at least 40 years old use of statins for lowering cholesterol from 2002 to 2013 studies. Such an extensive rise in the number of statinusers is driving the growth of the hyperlipidemia drug market. However, increasing side effects associated withstatin drugs is expected to hinder the growth of the statin drug market. Statins drugs have side effects and some patients are unable to bear it. For instance, atorvastatin and rosuvastatin are high-intensity statins which cause rare side effects like new-onset diabetes and muscle symptoms.

A Full Report of Global Hyperlipidemia Drug Market is Available at: https://www.omrglobal.com/industry-reports/hyperlipidemia-drug-market

Hence, the demand for non-statin drugs is expected to contribute to hyperlipidemia drug market growth in the near future. In 2020, the FDA has approved two non-statin drugs after a long period of the last 2 decades. For instance, in February 2020, The FDA approved the first non-statin oral medication for high cholesterol commercialized in the US and around the world. The drug, bempedoic acid, is the first in a new class of drugs to treat low-density-lipoprotein cholesterol.

Further, in February 2020, Esperion Therapeutics Inc received FDA approval for its Nexletol, a new type of cholesterol-lowering drug. This drug will help people manage their high cholesterol and reduce the risk of heart diseases. Further, other non-statin drugs for lowering cholesterol include PCSK9-targeting drugs such as Amgen’s Repatha (evolocumab), Sanofi’s Praluent (alirocumab) and inclisiran, developed by Alnylam Pharmaceuticals and The Medicines Company and currently under FDA review.

Global Hyperlipidemia Drug Market Segmentation

By Drug Class

HMG-CoA Reductase Inhibitors (Statins)

PCSK9 Inhibitors

Cholesterol Absorption Inhibitors

Fabric Acid Derivatives (Fibrates)

Niacin (Nicotinic Acid)

Bile Acid Sequestrants (BAS)

Combination Therapy and Compliance

Others

Global Hyperlipidemia Drug Market Segmentation by region

North America

United States

Canada

Europe

UK

Germany

Italy

Spain

France

Rest of Europe

Asia-Pacific

China

Japan

India

Rest of the Asia-Pacific

Rest of the World

Middle East & Africa

Latin America

For More Customized Data, Request for Report Customization @ https://www.omrglobal.com/report-customization/hyperlipidemia-drug-market

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Orion Market Research (OMR) is a market research and consulting company known for its crisp and concise reports. The company is equipped with an experienced team of analysts and consultants. OMR offers quality syndicated research reports, customized research reports, consulting and other research-based services.

Media Contact: Company Name: Orion Market Research Contact Person: Mr. Anurag Tiwari Email: info@omrglobal.com Contact no: +91 780-304-0404