BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril^[1] antibody, for the treatment of early Alzheimer's disease^[2] with confirmed amyloid pathology in the brain, to the Ministry of Food and Drug Safety (MFDS) in South Korea. This application is the first application for lecanemab in Asia outside of Japan and China. Eisai plans to continue further applications for approval in respective Asian countries.

The application is based on the results of the confirmatory Phase 3 Clarity AD study and the Phase 2b clinical study, which demonstrated that lecanemab treatment showed a reduction of clinical decline in early Alzheimer's disease (AD). 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 to slow down 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. BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.