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.
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