FDA Committee to Meet to Review EUA Application for COVID-19 Oral Treatment
On Thursday, the U.S. Food and Drug Administration (FDA) announced its Antimicrobial Drugs Advisory Committee (AMDAC) will meet on November 30 to review a request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19.
The drug, created by Merck and Ridgeback, is intended to treat mild-to-moderate 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 November 30 meeting, the FDA committee will receive presentations from the companies regarding the data for the antiviral drug, and the FDA will present its perspective regarding the sponsor’s data.
Additional information is available here.