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# Fast Track Designation for Lecanemab
- URL: https://www.fdaweb.com/fast-track-designation-for-lecanemab/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150822

FDA has [granted](https://www.biospace.com/article/releases/lecanemab-granted-fast-track-designation-by-the-fda/?ref=fdaweb.com) a fast track designation to lecanemab, BioArctic AB and Eisai’s investigational anti-amyloid beta protofibril antibody to treat early Alzheimer’s disease. The drug was granted breakthrough therapy designation in 6/2021.

Eisai started a rolling BLA submission for lecanemab under the accelerated approval pathway in 9/2021\. It says the BLA is primarily based on the clinical, biomarker, and safety data from a Phase 2b clinical study in people with early Alzheimer’s disease and confirmed amyloid pathology. Eisai says the study results demonstrated a high degree of amyloid beta plaque lowering and consistent reduction of clinical decline across several clinical endpoints.