FDA Authorizes Second Antiviral Pill To Treat COVID-19

By Jason Hall

December 23, 2021

Infectious doctor holding COVID 19 antiviral drug
Photo: Getty Images

The U.S. Food and Drug Administration authorized Merck's antiviral pill, molnupiravir, on Thursday (December 23), making it the second antiviral pill aimed to treat COVID-19 to receive authorization.

The agency confirmed the pill received authorization to treat the coronavirus "for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate," in a statement obtained by CNN.

Molnupiravir can be taken by individuals who have become ill from COVID-19 at home to avoid becoming severe enough for hospitalization.

Merck had already agreed to supply 3.1 million courses of the antiviral pill once it received authorization as part of an agreement with the U.S. government.

Molnupiravir was approved for recommendation by the FDA's advisers in a 13-10 vote at the end of November after a study showed it reduced hospitalization or death by 30% among high-risk adults who took it, far lower than previous analysis suggesting the estimated number would be around 50%.

The announcement comes hours after the FDA authorized the first COVID antiviral pill, Paxlovid, for patients age 12 and over considered to be vulnerable for severe illness, which was developed by Pfizer.

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