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FDA panel endorses COVID-19 pill from Merck

December 2021

A narrow vote from U.S. Food and Drug Administration advisers has approved the prescription of antiviral pills for treatment of COVID-19. The medicine was developed by Merck and Ridgeback Biotherapeutics. Although non-binding, the vote could clear the way for emergency use authorization.

On Tuesday, Nov. 30, a panel of the U.S. Food and Drug Administration’s outside drug advisers voted to endorse antiviral pills developed by Merck and Ridgeback Biotherapeutics.

The pills received approval to be prescribed for COVID-19 to treat the virus in high-risk adults. 

While not binding, the vote by the FDA’s Antimicrobial Drugs Advisory Committee could clear the way for the agency to grant emergency use authorization for adults. If authorized, the pill would be one of the first drug treatments that U.S. residents could take at home to treat COVID-19.

The Food and Drug Administration panel voted 13-10 that the antiviral drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. Recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Most experts backing the treatment stressed that it should not be used by anyone who is pregnant.

Specifically, approval grants that the drug may be used for adults with mild-to-moderate COVID-19 and face the greater risk, such as older people and those with conditions like obesity and asthma.

Health officials have said the pill should not be used in vaccinated people, who weren’t part of Merck’s research and haven’t been shown to benefit.