Britain approves Merck’s COVID-19 pill in world premiere

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 U.S.-based Merck & Co Inc (MRK.N) and Ridgeback Biotherapeutics, in a coup boost in the fight against the pandemic.

The UK Medicines and Health 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 illness , 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 onset of symptoms, the regulator said, citing clinical data.

The green light is the first for oral antiviral treatment for COVID-19 and the first for a COVID-19 drug that will be widely administered in the community. US advisers will meet on November 30 to review the drug’s safety and efficacy data and vote on whether or not to authorize molnupiravir. Read more

The pill, which will be dubbed Lagevrio in Britain, 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 linked to birth defects in animal studies. Merck, known as MSD outside of the United States and Canada, said animal testing showed molnupiravir to be safe, but the data has not yet been made public.

Treatment to fight the pandemic, which has killed more than 5.2 million people worldwide, has so far focused mainly on vaccines. Other options, including Gilead’s infused antiviral remdesivir (GILD.O) and the generic steroid dexamethasone, are usually not given until after the patient is hospitalized.

Merck’s Molnupiravir has been closely watched since data last month showed it could halve the chances of dying or being hospitalized for those most at risk of developing severe COVID-19 when it is given at the onset of the disease. Read more

Professor Stephen Powis, national medical director for the National Health Service (NHS) in England, said the drug would be given to patients at higher risk of complications as Britain heads into one of the harshest winters difficult all the time.

Wider deployment will follow if it is clinically and cost-effective to reduce hospitalizations and deaths, he added.

“We are now working within the government and the NHS to urgently provide this treatment to patients as a first step through a national study so that we can collect more data on how antivirals are working in a predominantly vaccinated population. British Vaccines Minister Maggie Throup told Parliament.

PRESSURES

Britain’s swift approval, which was also the first Western country to approve a COVID-19 vaccine, comes as it struggles to tame the spike in infections.

Britain has around 40,000 daily cases of COVID-19, according to the latest seven-day average. That’s just behind the roughly 74,000 a day in the United States, which has five times the population, and has fueled criticism of the government’s decision to drop most restrictions related to the pandemic.

Data released Wednesday evening showed the prevalence of COVID-19 in England reached its highest level on record last month, due to 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’ to protect the NHS from unsustainable demands, involving mask warrants, vaccine passes and work-from-home orders.

Many other major economies, including Germany, France and Israel, have either retained some basic COVID-19 measures like mask warrants or reintroduced them in response to the increase in cases.

The UK government has said it is still focusing on giving vaccine boosters and inoculating children 12 to 15 years old.

“Without any compromise on quality, safety and efficacy, the public can be confident that the MHRA has conducted a robust and in-depth evaluation of the data (on molnupiravir),” said MHRA Chief June Raine, in a press release.

Last month Britain struck a deal with Merck to get 480,000 courses of molnupiravir.

Professor Penny Ward, an independent pharmaceutical doctor, welcomed the approval but said the NHS had to present its deployment plans and warned that supplies would likely be limited given strong global demand.

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

If given to everyone who fell ill, the nearly half a million courses wouldn’t last very long given the current daily case rate of over 40,000, she said.

TREATMENT RACE

In a separate statement, Merck said it plans to produce 10 million treatments by the end of this year, of which at least 20 million are expected to be manufactured in 2022.

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

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

Merck and Pfizer are both 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, said Merck, including the more infectious Delta, which is responsible for the global surge in hospitalizations and deaths recently.

While it is not yet clear when Merck will deliver the doses to Britain, the company has said it is committed to providing rapid access to its drug globally with tiered pricing plans aligned with the a country’s ability to pay.

Merck licensed the drug to generic drug makers to supply it to low-income countries.

Antibody cocktails like those from Regeneron (REGN.O) and Eli Lilly (LLY.N) have also been approved for outpatient 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

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