On 1 April 2025, Eisai reported that the final process for the European Commission (EC) regulatory review of Eisai’s Marketing Authorisation Application (MAA) for Leqembi® (lecanemab) as a treatment for early Alzheimer’s disease (AD) is underway.
In February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed its positive opinion for Leqembi® for early Alzheimer’s disease. The EC has deliberated on the MAA in its Standing Committee and has now referred the decision to the Appeal Committee in accordance with the EC review process.
Leqembi® has been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland. Australia’s Therapeutic Goods Administration (TGA) declined to approve Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease.