Merck's COVID pill Lagevrio takes another hit with thumbs-down from EU regulator

The hits just keep on coming for Merck and Ridgeback Biotherapeutics’ COVID-19 pill Lagevrio.

Just three days after the companies reported that the oral antiviral flunked a trial testing its potential as a prophylaxis against household exposure, Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended against the authorization of Lagevrio for recently infected, at-risk patients, saying that the clinical benefit could not be demonstrated.

“Based on the totality of data, it was not possible to conclude that Lagevrio can reduce the risk of hospitalization or death or shorten the duration of illness or time to recovery in adults at risk of severe disease,” the CHMP concluded. “Furthermore, it was not possible to identify a specific group of patients with whom a clinically relevant benefit of Lagevrio could be demonstrated.”

Merck and Ridgeback will “appeal the decision and request a re-examination," the companies said in a release.

Lagevrio is authorized for use in more than 25 countries—including the United States, China, Japan and the U.K.—to treat patients who are at risk to progress to a severe form of the virus.

The drug has been administered to more than 4 million people in the world. It generated $5.7 billion in sales last year but earlier this month Merck said it expected 2023 sales to reach just $1 billion.

The decline comes after recent studies have shown the treatment to be less effective than previously indicated and as Pfizer’s rival drug Paxlovid has become the dominant oral antiviral used to combat COVID.

In October of 2021, there was much excitement over the first-of-its-kind pill when Merck announced that Lagevrio cut the risk of hospitalization and death in at-risk COVID patients by 50%. But in November, a day after the U.K. authorized the drug, Pfizer said that its rival antiviral cut the risk of hospitalization by 89%. A month later, the U.S. signed off on Lagevrio, but only after an FDA advisory committee voted 13-10 to recommend its use.

Six months before it was even authorized, the U.S. had bet big on Lagevrio’s potential, agreeing to pony up $1.2 billion for 1.7 million courses of the treatment. Today, of the 2.9 million courses of Lagevrio delivered to the U.S., only 1.1 have been administered, according to the Department of Health and Human Services. 

In July of last year, while the FDA decided to allow pharmacists to prescribe Paxlovid, the regulator didn’t extend the same privilege to Lagevrio.

Four months ago, a real-world study of Lagevrio in the U.K. showed that it did not reduce the risk of death or hospitalization in those who had been vaccinated. Then in November, England's National Institute for Health and Care Excellence (NICE) recommended against government coverage, along with the use of four other COVID products.