Eisai and Biogen get 'Breakthrough' status for Alzheimer's candidate lecanemab

The US Food and Drug Administration has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer’s disease (AD), under development by Japanese drug major Eisai (TYO: 4523) and US biotech Biogen (Nasdaq: BIIB).

Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions.

The news comes just a couple of weeks after Biogen and Eisai gained accelerated US regulatory approval for the use of its Aduhelm (aducanumab) as the first treatment in nearly two decades to address an underlying cause of Alzheimer's disease, but this historic approval has courted a great deal of criticism as to whether the FDA had behaved responsibly in clearing an unproven treatment with known harms.