Lecanemab granted Fast Track designation by the FDA to treat Alzheimer's disease.

The FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track designation are two FDA programs 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. The lecanemab Phase IIb study results demonstrated a high degree of Abeta plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Abeta plaque reduction and effect on clinical endpoints inStudy 201 further supports Abeta as a surrogate endpoint that is reasonably likely to predict clinical benefit.