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 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.
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. U.S. advisers will meet on Nov. 30 to review the drug’s safety and efficacy data and vote on whether molnupiravir should be authorized.
The pill, which will be branded as 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, has said animal testing shows that molnupiravir is safe, but the data have not yet been made public.
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.
Britain has about 40,000 daily cases of COVID-19, according to the latest seven-day average. That is second only to the roughly 74,000 a day in the United States, which has five times more people, and has fuelled criticism of the government’s decision to abandon most pandemic-related restrictions.
In a separate statement, Merck said it expected 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.
