FDA Schedules Advisory Committee Meeting to Discuss COVID-19 Oral Treatment
The U.S. Food and Drug Administration 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.
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.
Click
here for the FDA media release announcing the meeting
The FDA intends to live stream the
AMDAC meeting on the agency’s YouTube page
Preliminary results from a British
study released in June also showed promise.
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