FDA to hold advisory committee meeting to discuss EUA request from Merck and Ridgeback for oral treatment for COVID-19
SILVER SPRING, Md., October 14, 2021 / PRNewswire / – Today, the U.S. Food and Drug Administration announces an upcoming meeting of its Antimicrobial Drug Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s request for authorization to use emergency (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19[FEMININE[FEMININE
At November 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 are at high risk progression to severe COVID-19, including hospitalization or death.
“FDA Evaluates Safety and Effectiveness Data Submitted by Merck and Ridgeback in Their Emergency Use Authorization Application for Molnupiravir, a New Oral Treatment for People at High Risk with COVID-19 Infection newly diagnosed. We believe that, in this case, a public discussion of these data with the agency’s advisory board will help ensure a clear understanding of the data and scientific information that the FDA is evaluating in making a decision on whether or not to approve the drug. this treatment for emergency use, ”said Patrizia Cavazzoni, MD, director of the Center for Drug Evaluation and Research at the FDA.
At the discretion of the FDA, the agency may convene an advisory committee to seek advice from independent external experts on a variety of complex scientific, technical and policy issues. The FDA does not always call an advisory committee meeting as part of EUA reviews, but may do so in certain circumstances when the 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 application by the company. This timeline allows the FDA to thoroughly assess the data and information submitted in the EUA’s application prior to the meeting and prepare for a robust public discussion with members of the advisory committee.
During the meeting, the committee will hear presentations from the company regarding the antiviral drug’s data. The FDA will also present its perspective on the sponsor data. There will be an open public hearing during which the public will have the opportunity to provide comments.
The FDA intends to make the background materials for the AMDAC meeting, including the meeting agenda and list of committees, publicly available no later than two working days prior to the meeting. .
The FDA intends to live stream the AMDAC meeting on YouTube page; the meeting will also be webcast on the FDA website.
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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.
SOURCE US Food and Drug Administration