Britain approves Merck’s COVID-19 pill as a world first – Community News
Covid-19

Britain approves Merck’s COVID-19 pill as a world first

  • British approval for molnupiravir comes before US decision
  • UK and NHS confirm implementation plans in due course
  • VK completed just under half a million courses last month
  • Drug will be given to higher risk patients
  • Approval comes as UK struggles to tame infections

Nov. 4 (Reuters) – Britain on Thursday became the first country in the world to approve a potentially groundbreaking COVID-19 antiviral pill, jointly developed by US-based Merck & Co Inc (MRK.N) and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has recommended the drug, molnupiravir, for use in people with mild to moderate COVID-19 and at least one risk factor for developing serious diseases, such as obesity, diabetes in old age and heart disease. .

It will be administered as soon as possible after a positive COVID-19 test and within five days of the onset of symptoms, the regulator said, citing clinical data.

The green light is the first for an oral antiviral treatment for COVID-19 and the first for a COVID-19 drug to be widely delivered in the community. US advisers will meet on Nov. 30 to review the drug’s safety and efficacy data and vote on whether to approve molnupiravir. read more

The pill, which will be branded in Britain under the name Lagevrio, is designed to introduce errors into the genetic code of the coronavirus that causes COVID-19 and is taken twice a day for five days.

Drugs in the same class as molnupiravir have been associated with birth defects in animal studies. Merck, known outside the United States and Canada as MSD, has said animal studies show that molnupiravir is safe, but the data has not yet been made public.

Treatments to tackle the pandemic, which has killed more than 5.2 million people worldwide, have so far focused on vaccines. Other options, including Gilead’s (GILD.O) infused antiviral remdesivir and generic steroid dexamethasone, are generally only given after a patient is hospitalized.

Merck’s molnupiravir has been closely watched since data last month showed it could cut the risk of death or hospitalization in half for those most at risk of developing severe COVID-19 when given early in the disease. read more

Professor Stephen Powis, the national medical director of the National Health Service (NHS) in England, said the drug would be given to patients at higher risk for complications as Britain faces one of its most challenging winters ever.

A broader rollout will follow if it is clinically and cost-effective in reducing hospitalizations and death, he added.

“We are now working with the government and the NHS to get this treatment to patients urgently, initially through a national survey so that we can collect more data on how antivirals work in a largely vaccinated population,” the spokesperson said. UK Vaccine Secretary Maggie Throup to Parliament.

TO PRESS

The rapid approval in Britain, which was also the first Western country to approve a COVID-19 vaccine, comes as it struggles to tame rising infections.

Britain has about 40,000 daily cases of COVID-19, according to the latest seven-day average. That’s second only to the roughly 74,000 a day in the United States, which has five times more people, and has sparked criticism over the government’s decision to lift most pandemic-related restrictions.

Data released Wednesday evening shows that the prevalence of COVID-19 in England reached an all-time high last month, led by a high number of cases in children and an increase in the south west of the country. read more

Pressure is mounting on the government to implement its “Plan B” aimed at protecting the NHS from unsustainable demands, including mask mandates, vaccine passes and work from home orders.

An experimental COVID-19 treatment pill called molnupiravir being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP can be seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters on May 17, 2021. Merck & Co Inc/Handout via REUTERS

Many other major economies, including Germany, France and Israel, have either kept some basic COVID-19 measures, such as mask mandates, or reintroduced them in response to the increasing number of cases.

The UK government has said its focus will remain on administering vaccine boosters and vaccinating 12 to 15-year-olds.

“With no compromises in quality, safety and effectiveness, the public can be confident that the MHRA has conducted a robust and thorough review of the data[on molnupiravir],” MHRA chief June Raine said in a statement.

Last month, Britain agreed a deal with Merck to secure 480,000 courses of molnupiravir.

Professor Penny Ward, an independent pharmaceutical doctor, welcomed the approval but said the NHS had to outline its plans for the rollout and warned supplies will likely be tight given strong global demand.

“Comments from Mr. Javid today suggest it could be made available through a clinical trial, presumably to investigate its effectiveness in vaccinated patients with breakthrough infections, as the original study involved unvaccinated adults,” she said.

If everyone went unwell, the nearly half a million courses wouldn’t last long given the more than 40,000 daily cases, she said.

TREATMENT BREED

In a separate statement, Merck said it expects to produce 10 million courses of the treatment by the end of this year, with production of at least 20 million by 2022.

Shares of the US-based drugmaker rose 2.1%, closing at $90.54 on Thursday.

Pfizer (PFE.N) and Roche (ROG.S) are also racing to develop easy-to-administer antiviral pills for COVID-19.

Both Merck and Pfizer are studying their drugs in late-stage trials to prevent coronavirus infection.

Viral sequencing done so far has shown molnupiravir to be effective against all variants of the coronavirus, Merck said, including the more contagious Delta, which is responsible for the global increase in hospitalizations and deaths of late.

While it’s not yet clear when Merck will deliver doses to the UK, the company has said it is committed to providing timely access to its drug worldwide with tiered pricing plans tailored to a country’s ability to Pay.

Merck has licensed the drug to generic drug manufacturers for supply to low-income countries.

Antibody cocktails such as those from Regeneron (REGN.O) and Eli Lilly (LLY.N) are also approved for non-hospitalized COVID-19 patients, but must be administered intravenously.

Reporting by Pushkala Aripaka in Bengaluru and Josephine Mason in London; additional reporting by Kate Holton; Editing by Anil D’Silva and Mark Potter

Our Standards: The Thomson Reuters Trust Principles.