News | February 25, 2023
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.
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies
The company anticipates 2025 worldwide sales to be between $64.1 billion and $65.6 billion
Japan’s Ministry of Health, Labour and Welfare (MHLW) has recently approved AstraZeneca's long-acting antibody combination “Evusheld” for the prevention ) and treatment of COVID-19.
Based on a post hoc analysis, fewer required respiratory interventions
Among patients with infectious virus at baseline, no patients who received Lagevrio had infectious virus at days 3, 5 or 10
Merck has shared these additional analyses with the FDA and they will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on Nov. 30th
Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency
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