CHMP negative recommendation for Lagevrio for the treatment of patients with COVID 19. - Merck Inc., + Ridgeback Biotherapeutics.
Merck Inc., known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization for Lagevrio (molnupiravir) for the treatment of certain adults who have been diagnosed with COVID-19 in the European Union (EU). Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
“We believe the CHMP’s recommendation does not reflect the compelling data generated from the Phase III 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.”
The EMA scientific opinion under Article 5(3) of Regulation (EC) 726/2004, which has supported the decision by 16 EU national authorities to make Lagevrio available, remains in effect. Lagevrio is approved or authorized for use in more than 25 countries, including Australia, Japan, the United States, the United Kingdom, and China for the treatment of certain adults who have been diagnosed with COVID-19.
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