FDA advisory panel narrowly moves to authorize Merck's COVID treatment pill
The FDA itself still needs to officially authorize molnupiravir for people at high risk of severe COVID-19.
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A committee that advises the US Food and Drug Administration narrowly voted on Tuesday to support authorization of Merck's antiviral pill for treatment of people at high risk of severe COVID-19.
The agency will need to officially accept the panel's 13-10 vote in order for molnupiravir, created in partnership with Ridgeback, to be given emergency use authorization. If it's authorized, people who are at high risk of severe COVID-19 could be prescribed molnupiravir to take twice daily for five days, starting within five days of symptoms appearing.
Merck said Friday that its drug is 30% effective at preventing hospitalization and death caused by COVID-19. This is down from the company's previous estimate of a 50% reduction of hospitalizations and death. It was this change in the drug's efficacy, along with concerns about its safety profile, that held some members back from endorsing the treatment.
The FDA's potential authorization of the first oral antiviral treatment for COVID-19 comes as the world is grappling with the newest coronavirus variant, omicron. Pfizer has also asked the FDA to authorize its COVID-19 treatment pill, Paxlovid. In clinical trials, Pfizer said its COVID-19 treatment pill reduces risk of hospitalization or death by 89%.