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).

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.