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Monday, December 6th, 2021

FDA session to address COVID-19 oral treatment

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Food and Drug Administration (FDA) officials said the agency will conduct a Nov. 30 meeting via its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss a COVID-19 oral treatment.

The FDA indicated the effort would focus on Merck and Ridgeback’s request for an emergency use authorization (EUA) for molnupiravir.

“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said. “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.”

Authorities noted the session will focus on available data supporting molnupiravir’s use to treat COVID-19 in adults who have tested positive for the virus while at high risk for progression to severe COVID-19.

The committee is slated to hear presentations regarding antiviral drug data, officials said. The FDA will present its stance regarding the sponsor’s data and a public hearing will be conducted.