Eisai initiates submission of application data of lecanemab under the prior assessment consultation system in Japan with the aim of an earlier regulatory approval

Stockholm, March 4, 2022 – BioArctic AB:s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401). The lecanemab Clarity AD Phase 3 clinical study for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) is ongoing.

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