FDA Will Review Merck’s Covid Treatment Pill, But Not Just Yet
News outlets report on the Food and Drug Administration's plans for reviewing Merck's experimental oral antiviral treatment for covid, which won't happen until Nov. 30. The Philadelphia Inquirer, meanwhile, covers questions over the "unknown" risk of DNA mutations from the drug.
FDA Unlikely To Rule On Merck's COVID Pill Before December
The Food and Drug Administration said Thursday it will ask its outside experts to meet in late November to scrutinize Merck’s pill to treat COVID-19. The Nov. 30 meeting means U.S. regulators almost certainly won’t issue a decision on the drug until December, signaling that the agency will conduct a detailed review of the experimental treatment’s safety and effectiveness. The panelists are likely to vote on whether Merck’s drug should be approved, though the FDA is not required to follow their advice. (Perrone, 10/14)
FDA Will Review Merck's COVID-19 Pill
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. 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. (Garfinkel, 10/14)
Merck’s COVID-19 Pill And The ‘Unknown Risk’ Of DNA Mutation
The COVID-19 pill developed by Merck and Ridgeback Biotherapeutics appears to reduce the risk of hospitalization by inducing mutations in the coronavirus, preventing it from making copies of itself. Preliminary results from a clinical trial were so promising that the companies stopped it early, and asked the FDA this month for emergency authorization to market the antiviral drug. But in a study led by University of North Carolina researchers earlier this year, the drug also induced low levels of mutations in the DNA of hamster cells — in theory, suggesting it could pose a slight risk of cancer. (Avril, 10/14)