Merck & Co. Inc. (MRK) and privately held Ridgeback Biotherapeutics announced on Friday that a panel advising the European regulator had recommended refusing the marketing authorization for their jointly developed COVID antiviral for the treatment of certain adults. The companies said they would appeal the decision and request a review of the opinion, which was offered by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
The antiviral, called Lagevrio or molnupiravir, has been approved or authorized for use in more than 25 countries, including the U.S., Australia, Japan, the U.K. and China. It is mostly used in adults with mild-to-moderate COVID, who are at risk of developing severe disease.
Dr. Dean Y. Li, president of Merck Research Laboratories, commented on the CHMP’s recommendation, stating, “We believe the CHMP’s recommendation does not reflect the compelling data generated from the Phase 3 MOVe-OUT trial and from real-world 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. More than 4 million patients worldwide have been treated with LAGEVRIO. We remain confident that LAGEVRIO has an important role to play in the COVID–19 treatment landscape and will appeal this opinion.”
The news of the CHMP’s recommendation sent Merck stock lower premarket, but the stock has gained 50% in the last 12 months, while the S&P 500 (SPX) has fallen 6%.
The potential of Lagevrio to treat COVID-19 is a promising development in the fight against the virus. The antiviral is a novel drug that has been shown to reduce the risk of hospitalization and death in adults at increased risk for severe disease. The drug is also well tolerated, with only mild side effects reported in clinical trials.
The Phase 3 MOVe-OUT trial, which was conducted by Merck and Ridgeback, was the first randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Lagevrio for the treatment of mild-to-moderate COVID-19 in adults. The trial enrolled 1,822 patients in the United States, Canada, Mexico, and Brazil. The results of the trial showed that Lagevrio was associated with a statistically significant reduction in the risk of hospitalization or death due to COVID-19 compared to placebo.
The drug has also been studied in real-world studies, which have shown that it can reduce the risk of hospitalization and death in adults at increased risk for severe disease. In addition, the drug has been found to be well tolerated, with only mild side effects reported in clinical trials.
Given the promising results of the Phase 3 MOVe-OUT trial and real-world studies, Merck and Ridgeback are confident that Lagevrio has an important role to play in the COVID–19 treatment landscape. They plan to appeal the CHMP’s recommendation and are hopeful that the opinion will be reversed.
The news of the CHMP’s recommendation has sent Merck stock lower premarket, but the stock has still gained 50% in the last 12 months, while the S&P 500 (SPX) has fallen 6%. The potential of Lagevrio to treat COVID-19 is a promising development in the fight against the virus, and Merck and Ridgeback are confident that the drug has an important role to play in the COVID–19 treatment landscape. They plan to appeal the CHMP’s recommendation and are hopeful that the opinion will be reversed.
