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On September 27, Eisai announced that it has begun rolling submissions to the US FDA through the accelerated approval channel for its research Alzheimer's disease (AD) antibody therapy lecanemab biological product license application (BLA) for early treatment AD
The marketing application is mainly based on the clinical, biomarker and safety data of the Phase 2b clinical trial (Study 201) of lecanemab for early-stage AD patients
The Phase 3 clinical trial of Lecanemab for early AD (Clarity AD) is underway, and 1795 patients were enrolled in March 2021
Lecanemab (BAN2401) is a humanized monoclonal antibody intended for the treatment of AD.
In December 2007, Eisai and BioArctic signed an agreement to obtain the global research, development, production and marketing rights of lecanemab for the treatment of AD;
In March 2014, Eisai and Biogen signed a joint development and commercialization agreement for lecanemab, and the two parties revised the agreement in October 2017
In July 2020, a phase 3 clinical study (AHEAD 3-45) was launched for pre-clinical AD individuals (they are clinically normal, but the level of amyloid in the brain is moderate or high)
(The original text has been deleted)
Reference materials:
[1] Eisai Initiates Rolling Submission To The US FDA For Biologics License Application Of Lecanemab (BAN2401) For Early Alzheimer's Disease Under The Accelerated Approval Pathway.
