Last November, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the marketing authorisation application for lecanemab, an anti-amyloid immunotherapy for early Alzheimer’s disease which is marketed by Eisai and Biogen. The European Commission is the authorising body for all products approved by the EMA, and is responsible for issuing centralised marketing authorisation which is then valid in all EU member states, and in Iceland, Liechtenstein and Norway. This process must be completed within 67 days of receipt of a positive CHMP opinion.
On January 31, Biogen and Eisai announced that the European Commission, as part of its decision-making process, has asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of a positive opinion in November 2024. The European Commission has asked the CHMP to consider whether this information requires an update of the opinion, and whether the wording of the risk minimisation measures in the opinion is clear enough to ensure correct implementation. These measures will be discussed at the CHMP meeting in February 2025. Read the news update: