Britain approves Merck’s COVID-19 pill

Britain on Thursday became the first country in the world to approve a potentially groundbreaking COVID-19 antiviral pill jointly developed by Merck & Co Inc and the United States-based Ridgeback Biotherapeutics, in a boost to the fight against the pandemic.

Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) 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 of the old age and heart disease.

It will be administered as soon as possible after a positive COVID-19 test and within five days after symptoms begin, 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 administered widely in the community. US advisers will meet on November 30 to review the drug’s safety and efficacy data and vote on whether molnupiravir should be authorized.

The pill, which will be marked 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.

Medications in the same class as molnupiravir have been linked to birth defects in animal studies. Merck, known as MSD outside the United States and Canada, has said that animal tests show molnupiravir is safe, but the data has not yet been released.

Treatments to deal with the pandemic, which has killed more than 5.2 million people worldwide, have so far focused primarily on vaccines. Other options, including Gilead’s infused antiviral remdesivir and generic steroid dexamethasone, are usually only given after the patient has been hospitalized.

Merck’s molnupiravir has been closely watched since data last month showed it could cut the chances of dying or being hospitalized in half for people at higher risk of developing severe COVID-19 when given early in the illness. .

Professor Stephen Powis, national medical director of the National Health Service (NHS) in England, said the drug would be administered to patients at increased risk of complications as Britain enters one of the most challenging winters in history.

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

“We are now working across the government and the NHS to bring this treatment to patients urgently initially through a national study so that we can collect more data on how antivirals work in a largely vaccinated population,” the minister told parliament. UK Vaccine Officer, Maggie Throup.

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

Britain has around 40,000 daily COVID-19 cases, based on the latest seven-day average. That’s only surpassed by the roughly 74,000 a day in the United States, which has five times as many people, and has fueled criticism of the government’s decision to drop most of the pandemic-related restrictions.

Data released Wednesday night showed that the prevalence of COVID-19 in England reached its highest level on record last month, led by a high number of cases in children and an increase in the south-west of the country.

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.

Many other large economies, including Germany, France, and Israel, have withheld some basic COVID-19 measures as mask mandates or reintroduced them in response to the surge in cases.

The UK government has said its focus remains the administration of vaccine boosters and the inoculation of children aged 12-15 years.

BRITISH PRIME MINISTER Boris Johnson receives a dose of COVID-19 vaccine from Oxford / AstraZeneca earlier this month. (credit: FRANK AUGSTEIN / REUTERS)

“Without compromising quality, safety and efficacy, the public can trust that the MHRA has conducted a robust and comprehensive evaluation of the data (on molnupiravir),” MHRA Director June Raine said in a statement.

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

Independent Pharmacy Physician Professor Penny Ward welcomed the approval, but said the NHS needed to outline its implementation plans and cautioned that supplies are likely to be in short supply given strong global demand.

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

If given to everyone who gets sick, the nearly half a million courses would not last long due to the daily rate of more than 40,000 cases, he said.

In a separate statement, Merck said it expected to produce 10 million cycles of the treatment by the end of this year, with at least 20 million to be manufactured in 2022.

Shares of the US pharmaceuticals rose 2.1% to close at $ 90.54 on Thursday.

Pfizer and Roche are also competing 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 most 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 timely access to its drug globally with tiered pricing plans aligned with a country’s ability to pay.

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

Antibody cocktails like those by Regeneron and Eli Lilly have also been approved for non-hospitalized COVID-19 patients, but must be administered intravenously.

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