European Medicines Agency accepts Marketing Authorization Application for lecanemab as treatment for early Alzheimer’s disease: BioArctic

BioArctic AB’s (publ) partner Eisai announced that the European Medicines Agency (EMA) has accepted 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, for review following a standard timeline. In conjunction with EMA’s acceptance of the file, BioArctic is entitled to a milestone of MEUR 5.

In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway based on the results from the Phase III Clarity AD confirmatory study. In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. In China, Eisai has initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022.

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. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments in connection with regulatory filings, approvals, and sales milestones as well as royalties on global sales.