US Food and Drug Administration has announced 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.
The FDA intends to make background materials for the AMDAC meeting available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.
The FDA intends to live stream the AMDAC meeting on the agency’s YouTube page; the meeting will also be webcast from the FDA website.
