BRIEF—EC calls for update on regulatory review of lecanemab

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD) in the European Union.

In November 2024, a positive opinion was received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of lecanemab.

As part of its decision-making process, the European Commission (EC) has now asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation.