Merck & Co.'s COVID-19 pill received a negative recommendation from a European Union regulatory committee in a blow to efforts to gain clearance for marketing the medicine in the bloc.
The EU's Committee for Medicinal Products for Human Use couldn't conclude that the drug, Lagevrio, reduces the risk of hospitalization or death or shortens the duration of illness or time to recovery in adults at risk of severe disease, according to a statement Friday.
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The recommendation deepens the paucity of COVID drugs as most monoclonal antibodies have lost their effectiveness to new variants. Tests are being conducted to determine the effectiveness of additional antivirals such as Shionogi & Co.'s Xocova, which has so far only been cleared in Japan.
Merck developed the drug in collaboration with Ridgeback Biotherapeutics LP.
Recent studies have indicated that Merck's drug, also called molnupiravir, is less effective than early trials indicated. Adding Lagevrio to standard care didn't reduce hospitalizations or deaths in high-risk adults, according to a study released late last year, although it shortened the time to recovery from symptoms by several days.
The drug, which works by inducing genetic flaws in the coronavirus, also carries longstanding concerns about safety. US health officials recommend against its use in pregnant women and say it shouldn't be used when appropriate alternatives, such as Pfizer Inc.'s Paxlovid and Gilead Sciences Inc.'s remdesivir, are available.
The CHMP's decision doesn't reflect studies "demonstrating the positive impact that Lagevrio can provide for patients by reducing the risk of hospitalization and death among adults at increased risk for severe disease," Merck said in an emailed statement. "We will appeal the decision and request a re-examination of the CHMP's opinion."
