Panel At The FDA Selectively Recommends Merck Antiviral Coronavirus Pill

A Food and Drug Administration panel has decided to selectively recommend a new coronavirus antiviral pill from pharmaceutical company Merck, which is now paving the way for full approval.

According to a new report, a panel of physicians that have been organized by the FDA voted 13-10 to recommend that the agency give authorization for Merck’s antiviral pill, molnupiravir, for public use on Tuesday, coming to the conclusion that the possible benefits of the new treatment outweigh potential 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.,” Dr. Dean Y. Li, executive vice president of Merck, went on to say in a statement .

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via Washington Examiner:

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,” W. David Hardy of Charles Drew University School of Medicine and Science stated during a conversation concerning 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.

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.

Currently, there have been more than 48 million cases of the coronavirus here in the U.S., with more than 780,000 deaths being attributed to the illness, according to data from Johns Hopkins University.

How much of that information is accurate? Who knows? There’s been a lot of confusion over case numbers and some evidence has surfaced that indicates various hospitals might not have reported accurate numbers.

 


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