Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer's Disease

TOKYO and CAMBRIDGE, Mass. , Nov. 14, 2024 /PRNewswire/ -- Eisai Co.

, Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") and Biogen Inc. (Nasdaq: BIIB , Corporate headquarters: Cambridge, Massachusetts , CEO: Christopher A.

Viehbacher , "Biogen") announced today a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease (Early Alzheimer's disease) who are apolipoprotein E ε4 (ApoE ε4)* non-carriers or heterozygotes with confirmed amyloid pathology. 1 Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024. In accordance with European Medicines Agency regulatory process, the European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the CHMP recommendation within 67 days of receipt of CHMP opinion.

2 Lecanemab selectively binds to soluble Aβ aggregates (protofibrils**), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. 3 , 4 , 5 AD currently affects an estimated 6.9 million people in Europe , 6 and this figure is expected to nearly double by 2050 as aging popu.