A Food and Drug Administration panel has selectively recommended Merck’s COVID-19 antiviral pill, paving the way for approval.
A panel of doctors organized by the FDA voted 13-10 to recommend that the agency authorize Merck’s antiviral pill, named molnupiravir, for public use Tuesday, finding the known and potential benefits of the new treatment outweigh the possible risks.
“The positive outcome of today’s FDA Advisory Committee meeting, following a comprehensive review of molnupiravir is a critical step toward bringing this promising oral medicine for COVID-19 to appropriate patients in the U.S.,” said Dr. Dean Y. Li, executive vice president of Merck, in a statement.
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Members expressed concerns that the antiviral could cause birth defects if used by pregnant women, according to STAT News.
“I think we need to stop and acknowledge that the whole reason we’re having this discussion is because the efficacy of this product is not overwhelmingly good,” said W. David Hardy of Charles Drew University School of Medicine and Science during a discussion of the drug’s use while pregnant. “And I think that makes all of us feel a bit uncomfortable about the fact whether this is an advance therapeutically because it’s an oral medication, not an intravenous medication.”
Merck applied for emergency authorization of its oral antiviral on Oct. 1, when it became the first company to make a pill that can combat COVID-19’s symptoms. Despite early reports of the pill’s success in treating the virus, Merck revealed Friday that the antiviral pill might not be as effective as anticipated.
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Since then, Pfizer has submitted its own antiviral pill for emergency authorization as well. The U.S. government then purchased 10 million of Pfizer’s antiviral pills prior to FDA approval.
There have been more than 48 million cases of COVID-19 in the United States, with more than 780,000 deaths attributed to the virus, according to the Johns Hopkins University coronavirus tracker.
