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Lecanemab FDA Approval Status

Last updated by Judith Stewart, BPharm on May 10, 2022.

FDA Approved: No
Generic name: lecanemab
Company: Biogen Inc. and Eisai Co., Ltd.
Treatment for: Alzheimer's Disease

Lecanemab is an investigational humanized monoclonal antibody in development for the treatment of Alzheimer’s disease (AD).

  • Lecanemab is thought to slow down the progression of Alzheimer’s disease by neutralizing and eliminating soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that may contribute to the neurodegenerative process.
  • In June 2021, lecanemab was granted Breakthrough Therapy designation.
  • In September 2021, the Biologics License Application (BLA) for lecanemab in early Alzheimer’s disease was submitted to the FDA as a rolling submission under the accelerated approval pathway.
  • In December 2021, lecanemab was granted Fast Track designation.

    Breakthrough Therapy designation and Fast Track designation are two FDA programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as AD and provide opportunities for frequent interactions with the FDA.

Development timeline for lecanemab

DateArticle
May  9, 2022Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway
Apr 27, 2022Modeling Published in Neurology and Therapy Suggests that Lecanemab Could Delay Progression to Alzheimer's Dementia by Several Years
Dec 23, 2021Investigational Alzheimer’s Disease Therapy Lecanemab Granted FDA Fast Track Designation
Sep 27, 2021Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer's Disease Under the Accelerated Approval Pathway
Jun 23, 2021Eisai and Biogen Inc. Announce U.S. FDA Grants Breakthrough Therapy Designation for Lecanemab (BAN2401), an Anti-Amyloid Beta Protofibril Antibody for the Treatment of Alzheimer's Disease
Jul 25, 2018Eisai and Biogen Announce Detailed Results of Phase II Clinical Study of BAN2401 in Early Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2018
Jul  5, 2018Eisai and Biogen Announce Positive Topline Results of the Final Analysis for BAN2401 at 18 Months

Further information

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