The Union Democrat

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.

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