Eisai submits marketing authorization application for lecanemab in Japan

Eisai (ESALY) and Biogen (BIIB) announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease, or AD, and mild AD dementia with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency, or PMDA, of Japan. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.