European committee: Regulators should deny Merck’s Lagevrio
A European medical committee says regulators should reject Merck’s COVID-19 treatment Lagevrio for European Union use.
The drugmaker said that a European Medicines Agency committee has recommended marketing authorization refusal for the antiviral pill. More than two dozen countries have already approved or authorized the pill, including the United States.
Merck said Friday that it plans to appeal the recommendation from the Committee for Medicinal Products for Human Use.
Lagevrio and Pfizer’s pill treatment, Paxlovid, hit the market more than a year ago. They offer an easier way than IV medicines to treat patients with early COVID-19 symptoms who are at risk of serious illness.
Merck’s drug inserts tiny errors into the coronavirus’ genetic code to slow its reproduction. U.S. regulators have said it should be used cautiously.
The U.S. Food and Drug Administration authorized the treatment in late 2021 with restrictions. It cannot be used on patients under age 18. It also isn’t recommended for pregnant women because of the potential for birth defects.
The agency also has said Merck’s drug should be considered for patients “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”
Merck says more than 4 million patients worldwide have been treated with Lagevrio. It brough in about $5.7 billion in sales last year for Merck, which makes the treatment with Ridgeback Biotherapeutics. For 2023 Merck forecasts about $1 billion in Lagevrio sales.