On February 28, 2025, the European Union's human medicines committee (CHMP) announced that it is not updating its positive opinion on Eisai and Biogen's Alzheimer's drug, Leqembi. This decision follows a request from the European Commission to review additional safety information that became available after the CHMP initially recommended approval in November 2024.
The CHMP's confirmation means that the previous positive recommendation for Leqembi, indicated for early Alzheimer's disease in specific patient populations, remains unchanged. This outcome removes a layer of uncertainty that had emerged regarding the drug's path to final marketing authorization in the European Union.
Biogen and Eisai had previously stated their belief that the safety profile of Leqembi in clinical practice was consistent with approved labels and that no new safety signals had been identified. The CHMP's decision to not update its opinion reinforces the drug's safety and efficacy profile as evaluated by the European regulator, paving the way for the European Commission's final authorization.
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