Home United States USA — Political Merck’s Covid Treatment Pill Wins Blessing of F.D.A. Panel

Merck’s Covid Treatment Pill Wins Blessing of F.D.A. Panel

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The treatment, known as molnupiravir, could be authorized in the United States within days, and available within weeks, if the F.D.A. follows the committee’s recommendation.
A federal advisory committee on Tuesday voted to recommend that the government for the first time authorize the use of an antiviral pill to combat the worst effects of Covid-19. The advisory committee, in a surprisingly narrow 13-to-10 vote, endorsed the pill from Merck, while public health officials worldwide raced to buttress their defenses against the newly emerging Omicron variant of the coronavirus. The Merck treatment, known as molnupiravir, has been shown to modestly reduce the risk of hospitalization and death from Covid. The pill could be authorized for use in the United States within days and available to patients within weeks. In the coming weeks, the F.D.A. may also authorize a similar pill from Pfizer that appears to be significantly more effective than Merck’s. Together, the arrival of the two easy-to-use treatments could provide a cushion against a resurgent virus. The F.D.A. advisory panel, a group of experts on antimicrobial drugs, recommended that Merck’s treatment be authorized for people with Covid who are at high risk of becoming severely ill. That would most likely cover tens of millions of Americans who are older or have medical conditions such as obesity, diabetes or heart disease. But the committee’s close vote reflected doubts about the pill’s effectiveness and concerns that it could cause reproductive harm. “The efficacy of this product is not overwhelmingly good,” said Dr. David Hardy, an infectious disease physician in Los Angeles. Still, he voted to recommend the drug, saying “there is a need for something like this.” Other members of the committee who voted against authorization said more research was needed about the drug’s safety. “The risk of widespread effects on potential birth defects, especially delayed effects on the male, has not been adequately studied,” said Dr. Sankar Swaminathan, an infectious disease specialist at the University of Utah. The pills, which doctors will prescribe and will be dispensed at pharmacies, are much more convenient and are expected to reach many more people than the monoclonal antibody treatments that have typically been used to aid high-risk Covid patients. The antibody treatments are expensive and typically given intravenously at hospitals or clinics.

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