This undated image provided by Merck & Co shows their new antiviral medication against COVID-19. B
(MERCK & CO VIA AP)
Britain on Thursday became the first country in the world to approve a potentially game-changing COVID-19 antiviral pill jointly developed by US-based Merck and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic.
Britain's Medicines and Healthcare products Regulatory Agency recommended the drug, molnupiravir, for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease.
It will be administered as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms, the regulator said, citing clinical data.
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The green light is the first for an oral antiviral treatment for COVID-19 and the first for a COVID-19 drug that will be administered widely in the community. US advisers will meet this month to vote on whether molnupiravir should be authorized.
The drug, molnupiravir, to be branded Lagevrio in Britain, is designed to introduce errors into the genetic code of the virus that causes COVID-19 and is taken twice a day for five days
Treatments to tackle the pandemic, which has killed more than 5.2 million people worldwide, have so far focused mainly on vaccines. Other options, including Gilead's infused antiviral remdesivir and generic steroid dexamethasone, are generally only given after a patient has been 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 given early in the illness.
The drug, to be branded Lagevrio in Britain, is designed to introduce errors into the genetic code of the virus that causes COVID-19 and is taken twice a day for five days.
Professor Stephen Powis, national medical director for the National Health Service in England, said the drug would be administered to patients at higher risk of complications as Britain heads into one of the most challenging winters ever.
A wider rollout will follow if it is clinically and cost effective in reducing hospitalizations and death, he added.
The speedy approval in Britain, which was also the first Western country to approve a COVID-19 vaccine, comes as it struggles to tame soaring infections.
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This undated photo shows signage outside Merck & Co headquarters in Kenilworth, New Jersey. (CHRISTOPHER OCCHICONE / BLOOMBERG)
The country has about 40,000 daily cases of COVID-19, according to the latest seven-day average. That total is second only to the roughly 74,000 a day in the United States, which has five times more people.
Data released on Wednesday night showed COVID-19 prevalence in England hit its highest level on record last month, led by a high numbers of cases in children and a surge in the south-west of the country.
Viral sequencing done so far has shown molnupiravir is effective against all variants of the coronavirus, Merck has said, including the more-infectious Delta, which is responsible for the worldwide surge in hospitalizations and deaths recently
Pressure is growing on the government to implement its "Plan B" aimed at protecting the NHS from unsustainable demands, involving mask mandates, vaccine passes and work-from-home orders.
Many other big economies, including Germany, France and Israel, have either retained some basic COVID-19 measures like mask mandates or reintroduced them in response to rising cases.
The UK government has said its focus remains on administering vaccine boosters and inoculating 12 to 15-year-olds.
Last month, Britain agreed to a deal with Merck to secure 480,000 courses of molnupiravir.
Professor Penny Ward, an independent pharmaceutical physician, welcomed the approval, but said the NHS needed to outline its plans for rollout and cautioned that supplies were likely to be tight given the strong global demand.
In a separate statement, Merck said it was expecting to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.
The US-based drugmaker's shares were up 2.1 percent at $90.54 before the market open.
Pfizer and Roche are also racing to develop easy-to-administer antiviral pills for COVID-19. Pfizer last month began a large study of its oral antiviral drug for the prevention of COVID-19 in people exposed to the coronavirus.
Merck's molnupiravir is also being studied in a late-stage trial for preventing infection.
Viral sequencing done so far has shown molnupiravir is effective against all variants of the coronavirus, Merck has said, including the more-infectious Delta, which is responsible for the worldwide surge in hospitalizations and deaths recently.
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While it is not yet clear when Merck will deliver doses to Britain, the company has said it is committed to providing timely access to its drug globally with plans for tiered pricing aligned with a country's ability to pay.
Merck is also in talks with generic drugmakers about expanding manufacturing licenses to build supply of the treatment.
Antibody cocktails like those from Regeneron and Eli Lilly have also been approved for non-hospitalized COVID-19 patients, but have to be given intravenously.