Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a favorable opinion recommending the approval of the amyloid-beta monoclonal antibody, lecanemab. This treatment is intended for adult patients who have been clinically diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's disease or Early Alzheimer's disease, specifically targeting those who are apolipoprotein E e4 non-carriers or heterozygotes with confirmed amyloid pathology.
Following a previous negative opinion from CHMP in July 2024, Eisai had requested a re-evaluation.
As part of the regulatory process, the European Commission is anticipated to decide on the marketing authorization application (MAA) for lecanemab within 67 days following the CHMP's recommendation.
Eisai leads the global development and regulatory submissions for lecanemab, while both Eisai and Biogen are responsible for co-commercializing and co-promoting the treatment. Eisai retains the authority for final decision-making in these processes.