U.S. Food and Drug Administration announced Thursday that it will meet on November 30 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 valuable tool for tackling the pandemic. Merck ended its vaccine development in January.
running news: On Monday, Merck and Ridgeback submitted an emergency use authorization (EUA) for the drug, mollupiravir, in a clinical trial shortly after announcing the drug nearly reduced the risk of hospitalization or death from COVID-19. reduced by 50%.
- The FDA opted not to skip the advisory committee move, bloomberg news notes, which he can sometimes do to bring a drug to market faster. That means the drug may not be available to the public, if it is approved, until December or early next year.
description: The review will focus on whether available data support the use of mollupiravir in the treatment of mild to moderate COVID-19 cases in “adults who have tested positive for COVID-19, and who progress to severe COVID-19.” , including hospitalization or death,” according to the FDA release.
What are they saying: “We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure a clear understanding of the scientific data and information that the FDA makes in its decision about authorizing this treatment for emergency use.” is evaluating to take,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.