Eisai Co., Ltd. and Biogen’s lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer’s disease (AD), was granted Breakthrough Therapy designation from the FDA.
 
Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. The benefits of a Breakthrough Therapy designation includes more guidance on the development program and eligibility for rolling review and potentially priority review.
 
The designation for lecanemab is based on Phase 2b clinical trial results of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology. The proof-of-concept Study explored the impact of lecanemab on reducing brain amyloid beta (Abeta) and clinical decline. In this study, pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.
 
In March 2021 Eisai and Biogen completed enrollment of 1,795 patients with early AD in the Phase 3 Clarity AD study. The study’s primary endpoint is expected to be completed by the end of September 2022. Also, the Phase 3 trial, AHEAD 3-45, is currently exploring lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains. Open label extension data from Study 201 confirmed time-dependent reduction of brain Abeta in individuals newly treated with lecanemab.