FDA advisers recommend Merck's COVID-19 pill for authorization

A panel of advisers voted Nov. 30 to recommend the FDA authorize molnupiravir, the COVID-19 antiviral pill developed by Merck and Ridgeback Biotherapeutics.

The panel, which consisted of antimicrobial drug experts, recommended molnupiravir be authorized to treat people with COVID-19 who are at high risk of severe disease. The vote was narrower than expected at 13-10.

Panel members who voted against the drug's approval were concerned about its safety, efficacy and whether it would facilitate the virus's mutation into more dangerous variants, according to CNBC.

On Nov. 26, Merck released a final analysis of the drug showing it reduced the risk of hospitalization or death among high-risk patients by about 30 percent, down from 48 percent in an earlier analysis.

 

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