- A key committee of the European Medicines Agency has recommended against approval of Merck & Co. and partner Ridgeback Biotherapeutics’ COVID-19 pill Lagevrio, concluding that a clinical benefit for at-risk infected adults “could not be demonstrated.”
- The companies said Friday they will appeal the decision and ask the EMA to re-examine the negative opinion issued Thursday. Merck said Lagevrio remains available in 16 EU countries as supported by EMA’s advice in 2021 for its use before an EU-wide authorization.
- “We believe the [committee’s] recommendation does not reflect the compelling data generated from the Phase 3 MOVe-OUT trial and from real-world studies demonstrating [reduced] risk of hospitalization and death among adults at increased risk for severe disease,” said Merck’s research chief, Dean Li, in the company’s statement.
The negative decision contrasts with approvals of Lagevrio in 25 countries including the U.S., U.K, Japan and China, as well as the EU’s authorization of eight other COVID treatments including Pfizer’s antiviral pill Paxlovid.
The committee’s recommendation also marks a reversal of sorts in the EMA’s view of Lagevrio, as its 2021 advice to EU countries cited a 50% reduction in risk of hospitalization or death in initial results of the first 775 participants in Merck’s Phase 3 trial.
The committee’s latest rejection is based on additional data, including the full results of all 1,433 participants in the trial that showed less benefit, with 6.8% of those given Lagevrio having been hospitalized or died within 29 days of treatment, compared with 9.7% of those who received placebo.
The EMA’s human medicines committee also considered data from other studies and real-world use submitted by Merck. It is on these data that the committee said “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 committee also noted that it could not identify a specific group of patients in whom “a clinically relevant benefit of Lagevrio could be demonstrated.”
It is the second setback for Merck with Lagevrio this week. The drugmaker said Tuesday the pill failed in a large clinical trial to reduce the risk of getting COVID through household exposure to someone recently diagnosed with the disease. The results are similar to data for Paxlovid that also showed it failed to prevent household spread of the virus.
Like other makers of COVID treatments and vaccines, Merck forecast sales of Lagevrio to slow, projecting $1 billion in 2023 versus the $5.7 billion it recorded last year. Pfizer and Moderna have also significantly scaled back forecasts for their respective COVID products.
Merck sees potential for Lagevrio beyond COVID and recently started a study of it as a treatment for respiratory syncytial virus. Other companies are also pursuing treatments for RSV including AstraZeneca and Sanofi, which are awaiting an FDA decision on their antibody treatment, and Pfizer, which partnered with ReViral to advance an RSV treatment and could report preliminary trial data in late 2023.