: Merck and Ridgeback Biotherapeutics to appeal advisory panel to EU regulator’s decision to recommend refusing authorization of their COVID antiviral

Merck & Co. Inc. MRK and privately held Ridgeback Biotherapeutics said Friday a panel advising the European regulator has 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 antirival, 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. “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,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “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.” Merck stock was lower premarket, but has gained 50% in the last 12 months, while the S&P 500 SPX has fallen 6%.

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