Today, the European Medicines Agency has reaffirmed its positive opinion on lecanemab, following discussions at the February Committee for Medicinal Products for Human Use (CHMP) meeting.
On 31 January, Biogen and Eisai announced that the European Commission, as part of its decision-making process, had asked the CHMP to consider new information on the safety of lecanemab, their anti-amyloid immunotherapy for early Alzheimer’s disease. Lecanemab had previously received a positive opinion from the CHMP in November 2024, however the European Commission had asked the CHMP to consider whether this new information might require an update of the opinion. In particular, there were questions around the wording of the risk minimisation measures, and whether the opinion was clear enough to ensure correct implementation of these measures.
Following discussions at the February CHMP meeting, the European Medicines Agency announced that no updates would be required to its November opinion. This response has been provided to the European Commission, which will now resume the decision-making process for lecanemab.
Read more: https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi