Britain on Thursday became the first country in the world to approve a potentially game-changing COVID-19 antiviral pill jointly developed by U.S.A.-based MDS ("Merck & Co Inc" in the USA) and 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 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.A. 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. MSD, known as Merck in the United States and Canada, has said animal testing shows that molnupiravir is safe, but the data have not yet been made public.