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pharmaphorumuk · 4 years ago

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IL-6 drugs do work in COVID-19, says UK, as it plans NHS use

New data means that IL-6 drugs from Roche and Sanofi that had been all-but written off as coronavirus therapies will now be offered routinely to COVID-19 patients in intensive care in the UK.

The renaissance of the two therapies comes on the back of the REMAP-CAP trial, which found that the IL-6 inhibitors RoActemra (tocilizumab) and Kevzara (sarilumab) reduced the relative risk of death by 24% when administered to COVID-19 patients within 24 hours of entering intensive care, and reduce the time spent in hospital by seven to ten days.

Both RoActemra and Kevzara have failed to hit their objectives in earlier studies, leading to speculation that inhibiting IL-6 wasn’t a valid approach to treat severe COVID-19, but the new independent study turns that view on its head.

Crucially, their benefits seem to stack with that of the corticosteroid dexamethasone, the first drug to be shown to improve survival in seriously-ill COVID-19 patients in the RECOVERY trial.

The death rate for those in intensive care units on dexamethasone and respiratory support alone was 35%, but reduced to 28% when RoActemra was administered as well.

“The data shows that tocilizumab, and likely sarilumab, speed up and improve the odds of recovery in intensive care, which is crucial for helping to relieve pressure on intensive care and hospitals and saving lives,” said UK deputy chief medical officer Prof Jonathan Van-Tam.

The data has emerged as the government unveiled figures showing there are currently around 30,000 COVID-19 patients in hospitals, up nearly 40% on the previous peak during the first wave of the pandemic in April.

There are already ample supplies of RoActemra in the UK, so that drug in particular will be recommended for use “immediately” in patients admitted to intensive care with the virus, it said, saying that could potentially save “hundreds of lives”.

Roche welcomed the results, saying it was still in the process of analysing data from the COVACTA and EMPACTA trials, which generated negative and positive results for its drug respectively in patients hospitalised with COVID-19 associated pneumonia.

“Previous trials using IL-6 receptor agonists have showed no clear benefit on either disease progression or survival in COVID-19 patients, but those studies included less severely ill patients and started treatment at different stages in the disease course,” said Professor Anthony Gordon of Imperial College London, the trial’s lead investigator in the UK.

“A crucial difference may be that in our study, critically ill patients were enrolled within 24 hours of starting organ support. This highlights a potential early window for treatment where the sickest patients may gain the most benefit from immune modulation treatment,” he added.

REMAP-CAP has been running since 2016, with the aim of putting dozens of drugs through their paces to see if they can improve the prospects of people with severe community-acquired pneumonia (CAP) caused by influenza, but was expanded to include COVID-19 patients after the pandemic took hold.

It included more than 800 pneumonia patients in intensive care with suspected or proven COVID-19, of which around three-quarters were recruited from UK NHS trusts, but hasn’t yet been subjected to the scrutiny of peer review.

“This news is a positive step in the fight against COVID-19, giving doctors and the NHS another weapon in their armoury to treat critically ill patients,” said Marius Scholtz, chief medical officer at Roche Products Ltd. “It also increases the collective scientific understanding of COVID-19.”

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from https://pharmaphorum.com/news/il-6-drugs-covid-19-new-trial/

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pharmaphorumuk · 7 years ago

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Roche’s MS drug Ocrevus priced in line with Novartis rival in UK

Roche has said it plans to UK price its latest multiple sclerosis drug Ocrevus in line with its close rival from Novartis – aiming to undercut some established rivals.

Approved in Europe earlier this month, Ocrevus (ocrelizumab) offers a new treatment option for patients with relapsing disease.

It is also the first drug approved for patients with primary progressive MS (PPMS), where symptoms get worse over time.

In an interview with pharmaphorum, Marius Scholtz, country medical lead for Roche UK, said the drug will have around the same yearly cost in relapsing disease as Novartis’ once-daily pill, Gilenya (fingolimod).

He told pharmaphorum: “The price will be similar to other highly effective medicines. It will not be the most expensive but it will not be the cheapest – a very effective drug at the same list price as Gilenya.”

When NICE assessed Gilenya back in 2012, it said the drug costs the NHS £19,169 per person annually, based on a price of £1,470 for 28 capsules.

Although Novartis also offered a commercially confidential discount for Gilenya in order to get it past NICE, this gives a ball-park indication of the cost of Ocrevus.

As Ocrevus is given twice a year once, after two initial infusions two weeks a part, this points to a cost of just under £10,000 per infusion, although Scholtz would not give a precise figure.

It’s highly likely that Roche will also have to offer a discount in order to get Ocrevus reimbursed, as most medicines do not make it through the NICE process at full price.

In the US, Roche has already got a chunk of the market by undercutting German Merck’s Rebif (interferon beta 1a) – but prices in the UK could well change as part of a review of MS drug prices by NICE that began late last year.

NICE is threatening to end funding for five established MS drugs because a risk sharing scheme that has been in place since 2001 has come to an end.

Scholtz said it has just begun the process of getting Ocrevus assessed by NICE in relapsing disease, and is preparing a separate dossier for its use in primary progressive disease.

Roche will be meeting with NICE in the coming months to begin the appraisal process for relapsing disease, said Scholtz.

PPMS delays

But he warned that Ocrevus will likely be later to market in PPMS because of its first-to-market status in that indication.

Roche’s Marius Scholtz

“In PPMS we are still working on our submission – it is slightly more complex and will require more work to get into NICE. It will require a different review because the patient populations are very different,” said Scholtz.

The company hopes to get NICE to approve regular NHS funding for Ocrevus by the end of the year, said Scholtz.

But he added: “In PPMS it will be the first drug to go through the process so we are not sure how long it will take. It might take substantially longer.”

In PPMS, Ocrevus is likely to be assessed using NICE’s standard technology appraisal process, rather than special pathways reserved for rare or very rare diseases.

Ocrevus is already a huge hit in the US, where it has generated revenues of around $500 million in its first six months or so on the market.

In the UK, drugs that cost more than £20 million in any of their first three years or so on the market are subject to a further review by NICE – but Scholtz said it was too early to say whether this restriction will apply to Ocrevus.

“It is very early in the process and it is difficult to know if we are likely to meet that threshold,” said Scholtz.

Crowded market

Ocrevus is competing in a crowded market for MS drugs, but looks likely to have advantages over already marketed rivals.

Along with strong efficacy figures in relapsing disease, trial evidence does not show a link with the rare but deadly brain disease progressive multifocal leukoencephalopathy (PML) – seen in certain patients treated with Biogen’s Tysabri (natalizumab).

Although one patient treated with Ocrevus has reportedly developed PML, Roche blamed this on previous treatment with Tysabri.

And while Biogen’s Tecfidera (dimethyl fumarate) pill is also commonly used, it is associated with unpleasant gastrointestinal side effects.

This did not occur in trials of Ocrevus, which is unlikely to produce these issues as it is infused – itching, rash and difficulty breathing are listed the most common side effects with the Roche drug.

Merck KGaA’s recently approved MS pill Mavenclad (cladribine) is also available to NHS patients after the company agreed to only charge for patients that respond to the treatment.

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from Pharmaphorum https://pharmaphorum.com/news/roches-ocrevus-priced-line-gilenya-uk/

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