On January 31, 2025, Eisai Co., Ltd. and Biogen Inc. announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (LEQEMBI) in the European Union. The European Commission (EC) requested the Committee for Medicinal Products for Human Use (CHMP) to consider safety information on lecanemab that became available after the CHMP's positive opinion in November 2024.
The EC's request also includes a review of whether the wording of the risk minimization measures in the opinion is sufficiently clear to ensure correct implementation. These points are scheduled for discussion at the CHMP meeting in February 2025. This development introduces additional scrutiny, potentially delaying the final authorization of Leqembi in the EU.
Biogen and Eisai maintain that the safety profile of lecanemab observed in clinical practice in the United States, Japan, and other countries post-launch is consistent with approved labels, and no new safety signals have been identified. They believe the EC’s requests can be addressed with existing information and will be evaluated by the CHMP, as they continue to work towards approval in the EU.
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