Eisai announced that Eisai has submitted a marketing authorization application (MAA) for lecanemab, an investigational anti-amyloid beta (Aß) protofibril antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) to the European Medicines Agency (EMA). This application is based on the results of the Phase 3 Clarity AD study and the Phase 2b clinical study, which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD. The application is subject to a validation to determine whether the EMA accepts the application for review.

In conjunction with the regulatory filing to EMA announced today, and the subsequent acceptance of the file by EMA, BioArctic is entitled to a milestone of MEUR 5. The Clarity AD study met its primary endpoint (CDR-SB: Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journals.

In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the Food and Drug Administration (FDA) on January 6, 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day. In China, Eisai has initiated submission of data for a BLA to the National Medical Products Administration (NMPA) in December 2022.

In Japan, Eisai plans to submit a marketing authorization application by the end of the first quarter 2023. 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. BioArctic has right to commercialize lecanemab in the Nordic under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai.