FDA to hold Advisory Committee Meeting to discuss application for COVID-19 oral treatment

The U.S. Food and Drug Administration is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19.

On Nov. 30, the advisory committee will meet to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

During the meeting, the committee will hear presentations from the company regarding the data for the antiviral drug. The FDA will also present its perspective regarding the sponsor’s data. There will be an open public hearing during which the public will be given an opportunity to provide comments.

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