tokyo and cambridge, mass., may 22, 2023 – 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 that eisai has submitted a marketing authorization application (maa) for lecanemab, an investigational anti-amyloid beta (aβ) protofibril antibody, for the treatment of early alzheimer’s disease (mild cognitive impairment due to alzheimer’s disease (ad) and mild ad dementia) with confirmed amyloid pathology in the brain, to the uk medicines and healthcare products regulatory agency (mhra) in great britain. lecanemab has been designated by the mhra for the innovative licensing and access pathway (ilap).
the maa is based on the results of the confirmatory phase iii clarity ad study and phase iib clinical study (study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early ad, and is subject to a validation to determine whether it will be accepted by the mhra. lecanemab selectively binds and eliminates soluble, toxic aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in ad. as such, lecanemab may have the potential to have an effect on disease pathology and the progression of the disease. the clarity ad study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
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.