Merck & Co.’s COVID-19 pill gained a key recommendation from advisers to U.S. regulators, increasing the likelihood that the treatment for high-risk patients will be cleared for use in the United States.
The Food and Drug Administration’s advisory committee voted 13-10 to back Merck’s antiviral drug molnupiravir, saying the benefits outweigh the risks.
The pill is intended to treat mild-to-moderate COVID-19 in adults at risk of developing severe illness. Merck developed the treatment with partner Ridgeback Biotherapeutics LP.
The decision comes amid rising concerns about a new coronavirus variant that is described by scientists as different from previous incarnations and potentially of serious concern. Pfizer Inc. and partner BioNTech SE, Moderna Inc. and Johnson & Johnson are working to adapt their COVID-19 vaccines to address the omicron variant.
The FDA isn’t obligated to follow the recommendations of the panel, called the Antimicrobial Drugs Advisory Committee, though it typically does. A decision from the agency on whether to clear the pill could come soon after the meeting concludes Tuesday.
The pill could be a game-changer in the fight against the pandemic by turning COVID-19 into an illness that is easily treated outside a hospital setting. That may relieve the strain on health systems stretched thin by staffing shortages and rising infection levels.
Unlike other COVID-19 antivirals that are administered via intravenous infusion usually in hospitals or clinics, a five-day course of molnupiravir can be taken by patients at home.
Regulators have already allowed Merck’s pill to be used in emergency treatment of adults in the European Union. It hasn’t been formally authorized for sale.
Pfizer is also pursuing FDA authorization for its own antiviral COVID-19 pill.