Eisai completes rolling submission to the FDA of lecanemab for early Alzheimer’s disease under the accelerated approval pathway

Stockholm, May 10, 2022 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401), for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. In conjunction with the completed regulatory filing to the FDA announced today, and the subsequent acceptance by the FDA of the file, BioArctic is entitled to a milestone of MEUR 15.

The release as fetched from its publisher. bioarctic.com ↗