EMA recommends refusal of the marketing authorization for Lagevrio
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EMA recommends refusal of the marketing authorization for Lagevrio

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.

  • By IPP Bureau | February 25, 2023

Merck 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 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.”

“LAGEVRIO is prescribed globally as an important medicine for appropriate adult patients at risk for severe disease, and there is a critical need for multiple approaches to treat COVID-19,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics.

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.

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