The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for the treatment of Alzheimer disease.

The designation is based on data from a randomized, double-blind, phase 2b proof-of-concept trial ( Identifier: NCT01767311) that evaluated lecanemab in 856 patients with mild cognitive impairment due to Alzheimer disease and mild Alzheimer disease with confirmed presence of amyloid pathology. Pre-specified analysis showed that lecanemab at the highest doses demonstrated consistent reduction of clinical decline across several clinical and biomarker endpoints.

Lecanemab is currently being investigated in the phase 3 Clarity AD study ( Identifier: NCT03887455) in 1795 patients with early Alzheimer disease; the study has completed enrollment as of March 2021. Lecanemab is also being evaluated in the phase 3 AHEAD 3-45 study ( Identifier: NCT04468659) in individuals with preclinical Alzheimer disease, defined as patients who are clinically normal but have intermediate or elevated levels of amyloid in the brain.

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Eisai and Biogen Inc. announce US FDA grants Breakthrough Therapy designation for lecanemab (BAN2401), an anti-amyloid beta protofibril antibody for the treatment of Alzheimer’s disease. [press release]. Tokyo, Japan and Cambridge, MA: Eisai Co., Ltd. and Biogen Inc.; June 23, 2021. 

This article originally appeared on MPR