U.S. FDA panel narrowly backs Merck's at-home COVID-19 pill

U.S. FDA panel narrowly backs Merck's at-home COVID-19 pill A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's antiviral pill to treat COVID-19. Michael Erman,Manas Mishra Reuters

Nov 30 (Reuters) - A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's (MRK.N) antiviral pill to treat COVID-19.

If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency.

Merck published data last week suggesting the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.

"COVID-19 is still an emergency situation," said committee member Dr. David Hardy, who voted yes. "There is a need for something like this. This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderately symptomatic persons would be available, although I do have questions about its overall longer-term efficacy." ...

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