Eisai Gets Positive Opinion From CHMP In European Union For Lecanemab In Early Alzheimer's Disease

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(RTTNews) - Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending approval of the amyloid-beta 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 or Early Alzheimer's disease who are apolipoprotein E e4 non-carriers or heterozygotes with confirmed amyloid pathology.

Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024.

As per 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.

Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

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