Posted by Michael Wonder on 28 Sep 2021
Eisai initiates rolling submission to the U.S. FDA for biologics license application of lecanemab (BAN2401) for early Alzheimer's disease under the accelerated approval pathway
28 September 2021 - Eisai and Biogen today announced that Eisai has initiated a rolling submission to the U.S. FDA of a biologics license application for lecanemab (BAN2401), the company’s investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer’s disease.
The biologics license application is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early Alzheimer's disease and confirmed amyloid pathology.
