Fast track designation for Alzheimer's candidate lecanemab

Hot on the heels of Japanese rejection of a regulatory filing for their controversially US approved Aduhelm (aducanumab), Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) today announced that lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), has been granted Fast Track designation by the US Food and Drug Administration. Eisai’s shares edged up 1.4% to 6,569 yen on the news.

The FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. These are both designations that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as AD and provide opportunities for frequent interactions with the FDA.

In September 2021, Eisai initiated a rolling submission to the FDA of a Biologics License application (BLA) for lecanemab under the accelerated approval pathway. The BLA is primarily based on clinical, biomarker and safety data from the Phase IIb clinical study (Study 201) in people with early AD and confirmed amyloid pathology, and non-clinical and clinical parts of the application which consists of three parts (non-clinical, clinical and CMC) have already been submitted.