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.
“The FDA is evaluating the safety and effectiveness data submitted by Merck and Ridgeback in their emergency use authorization request for molnupiravir, a new oral treatment for high-risk individuals with a newly diagnosed COVID-19 infection. We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
At the FDA’s discretion, the agency may convene an advisory committee to solicit advice from independent outside experts on various complex scientific, technical, and policy issues. The FDA does not always convene an advisory committee meeting in connection with EUA reviews, but may do so under certain circumstances when discussion with the advisory committee will help inform agency decision making.
The meeting was scheduled as soon as possible following the submission of the EUA request by the company. This timeline allows for the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.
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.
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.