Eisai starts filing for FDA appro of Alzheimer's candidate lecanemab

Japanese drug major Eisai (TYO: 4523) said today that it has initiated a rolling submission to the US Food and Drug Administration of a Biologics License Application (BLA) for lecanemab (BAN2401), the company’s investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (early AD). The drug is being developed in partnership with US biotech Biogen (Nasdaq: BIIB).

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase IIb clinical trial (Study 201) in people with early AD and confirmed amyloid pathology. The lecanemab Phase IIb trial results demonstrated a high degree of Aβ plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Aβ plaque reduction and effect on clinical endpoints in Study 201 further supports Aβ as a surrogate endpoint that is reasonably likely to predict clinical benefit. AD is a serious, progressive and devastating disease with few treatment options. Eisai is utilizing the accelerated approval pathway after discussion with the FDA and aims to bring a new treatment option to people living with early AD, their families and healthcare professionals.

The development comes in the wake of Biogen and Eisai’s Aduhelm (aducanumab-avwa) clearance, which, somewhat controversially, in June became the first treatment in two decades to gain approval in the treatment of Alzheimer’s disease.