The Food and Drug Administration will ask its outside experts to meet in late November to scrutinise Merck’s pill to treat Covid-19.
The November 30 meeting means US regulators likely won’t issue a decision on the drug until December, signalling 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 authorised since last year but they are expensive, hard to produce and require specialty equipment and health professionals to deliver.
If authorised, Merck’s drug, molnupiravir, would be the first that patients could take at home to ease symptoms and speed recovery.
If authorised, 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.