Merck COVID pill gains US clearance for high-risk adults

Merck & Co.’s COVID-19 pill was cleared by U.S. regulators, giving high-risk patients another at-home treatment option at a time when the omicron variant is causing cases to surge.

The drug, molnupiravir, received emergency authorization on the heels of Pfizer Inc.’s competing pill that was cleared Wednesday, Paxlovid. Together, the treatments promise to provide a new way to keep a sharp rise in infections from overwhelming U.S. hospitals.

Molnupiravir, developed by Merck with partner Ridgeback Biotherapeutics LP, is intended to treat COVID in nonhospitalized people 18 and older at risk of developing severe illness. A study showed it reduced the risk of hospitalization or death among adults with mild to moderate disease by 30%.

Molnupiravir works by introducing errors in genetic material to ultimately stop the virus’s replication, but it may affect growing human cells. The FDA said that pregnant people be advised of potential risks to the fetus before receiving the drug.

In November, a panel of outside advisers to the FDA debated whether the drug was safe for wide use. Some expressed concern that it could lead to mutations in the virus that might make it more dangerous or transmissible, or that it could pose risks for pregnant people, and that its low efficacy in the clinical trial meant its risks outweighed its benefits. Ultimately, a divided panel voted to back the treatment by a narrow margin.

Merck has said molnupiravir doesn’t pose longterm risks.

Currently, patients who could become seriously ill with COVID are given infused drugs in hospitals or clinics, whereas a five-day course of molnupiravir can be taken at home.