The Latest: FDA likely to rule on virus pill in December
Pfizer, Roche and Appili Therapeutics are studying similar drugs.
WASHINGTON (AP) — The Food and Drug Administration 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 likely 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, although the FDA is not required to follow their advice.
Three IV antibody drugs have been authorized since last year but they are expensive, hard to produce and require specialty equipment and health professionals to deliver. If authorized, Merck’s drug, Molnupiravir, would be the first that patients could take at home to ease symptoms and speed recovery.
If authorized, Merck’s drug is likely the first — but not the only — pill to treat COVID-19. Pfizer, Roche and Appili Therapeutics are studying similar drugs.