CHMP Reaffirms Lecanemab

Eisai Co., Ltd. and Biogen Inc.  announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has reaffirmed its positive opinion by consensus for the anti-Aβ monoclonal antibody lecanemab, adopted in November 2024.    Following CHMP’s reaffirmation, after having considered the additional information requested by the European Commission (EC), the EC will resume the decision-making process for lecanemab's marketing authorization. In January 2025, as part of its decision-making process, the EC 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. After reviewing the additional information, the CHMP concluded that its positive opinion for lecanemab does not need to be updated.