Oct 14, 2021 - Health

FDA will review Merck COVID-19 pill

The Merck logo. Photo Illustration by Igor Golovniov/SOPA Images/LightRocket via Getty Images.

The U.S. Food and Drug Administration announced on Thursday that it will meet on Nov. 30th to review Merck's experimental oral antiviral COVID-19 treatment

Why it matters: An oral antiviral drug designed to prevent or treat COVID-19 could be a key tool to combat the pandemic. Merck ended its vaccine development in January.

Driving the news: On Monday, Merck and Ridgeback submitted an emergency use authorization (EUA) for the drug, molnupiravir, soon after announcing the drug reduced the risk of hospitalization or death from COVID-19 by about 50% in a clinical trial.

  • The FDA opted not to skip the advisory committee step, Bloomberg News notes, which it can do occasionally to get a drug to market faster. That means the drug might not be available to the public, if approved, until December or early next year.

Details: The review will focus on whether the available data supports the use of molnupiravir in treating mild-to-moderate COVID-19 cases in "adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death," per the FDA release.

What they're saying: "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," said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

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