08:09 AM EST, 01/31/2025 (MT Newswires) -- Biogen (BIIB) and Eisai said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use is expected to discuss in February additional safety data on lecanemab as treatment for early Alzheimer's disease.

The committee recommended the approval of lecanemab in November 2024, but was asked by the European Commission to consider safety data that became available after the committee issued its positive opinion, according to the companies.

The Commission is asking the CHMP whether its opinion may require an update, and whether the wording of risk minimization measures in the opinion is clear enough for correct implementation, the companies added.

"We believe that the EC's requests can be addressed with existing information and will be evaluated by the CHMP because of the clear and sufficient information available," the companies said in a statement.