FDA to hold advisory committee for Merck’s experimental COVID-19 pill

Shares of Merck & Co. Inc. were down 0.1% in premarket trading on Friday, the day after the Food and Drug Administration said it plans to convene an advisory committee on Nov. 30 to discuss the company’s experimental COVID-19 pill, molnupiravir. Merck is developing the antiviral with the privately held Ridgeback Biotherapeutics; it recently applied for emergency authorization. The FDA requested advisory committee meetings for each of the authorized COVID-19 vaccines but it did not convene one ahead of the authorizations of the monoclonal antibodies or Gilead Sciences Inc.’s remdesivir, an antiviral used to treat severely ill COVID-19 patients that is now fully approved. “We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. Merck’s stock is up 0.4% for the year, while the S&P 500 has gained 18.1%.

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