On Jun. 23, 2021, Biogen and Eisai announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A) protofibril antibody for the treatment of Alzheimer’s disease (AD).

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 include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review.

The FDA’s Breakthrough Therapy designation for lecanemab was based on published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.