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
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