COVID Pill Treatment Closer to Emergency Use Authorization

The Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has recommended emergency use authorization (EUA) of molnupiravir. The oral capsule medication made by Merck is designed to treat “mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization,” says the FDA.  

The recommendation next goes to the FDA for approval, which is expected. Some on the advisory committee voted against authorization because its effect on pregnant people is not known. Merck told the committee that while the drug had not been tested against the Omicron variant, they had “every expectation” it would work.  

The FDA also issued a statement on its investigation and action on the Omicron variant. The statement includes links to updated information on use and limitations of monoclonal antibodies, fact sheets on variants and therapeutics, and testing and variants.  


Topics: Guidance

Written by Argentum

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