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 (ClinicalTrials.gov 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 (ClinicalTrials.gov 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 (ClinicalTrials.gov 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.
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.