Investigational Alzheimer Disease Treatment Granted Fast Track Status

The FDA granted lecanemab Breakthrough Therapy designation back in June, 2021.

The Food and Drug Administration (FDA) has granted Fast Track designation to lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for early Alzheimer disease (AD).

Lecanemab is a humanized monoclonal antibody that works by selectively binding to, neutralizing and eliminating soluble toxic amyloid beta aggregates. In September 2021, Eisai submitted a Biologics License Application (BLA) to the FDA for lecanemab for the treatment of early AD. The BLA was supported by data from a phase 2b study ( Identifier: NCT01767311) which included 856 individuals with early AD and confirmed amyloid pathology.

Findings showed that treatment with lecanemab was associated with reduced brain amyloid beta plaque, correlating with improvements in cognitive decline based on the Alzheimer Disease Composite Score, the Clinical Dementia Rating-Sum-of-Boxes, and the Alzheimer Disease Assessment Scale-Cognitive Subscale.  

Lecanemab is currently being investigated in the confirmatory phase 3 Clarity AD study ( Identifier: NCT03887455) in 1795 patients with early AD; the study has completed enrollment as of March 2021. A separate phase 3 AHEAD 3-45 study ( Identifier: NCT04468659) is evaluating lecanemab in cognitively normal participants with preclinical AD and elevated amyloid, and in individuals with early preclinical AD and intermediate amyloid.

The FDA also granted lecanemab Breakthrough Therapy designation in June 2021 for the treatment of AD.


Lecanemab granted Fast Track designation by the FDA. News Release. December 23, 2021. Accessed December 27, 2021.