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Investigational Alzheimer's disease drug lecanemab receives US FDA Fast Track designation

 Last Update: 2022-02-23
 Source: Internet
 Author: User

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On December 28, Eisai and Biogen announced that lecanemab, an investigational anti-amyloid beta (Aβ) fibril antibody for the treatment of early Alzheimer's disease (AD), has been approved by the U.

In September 2021, Eisai began rolling submissions of a Biologics License Application (BLA) for lecanemab to the FDA under the accelerated approval pathway

A Phase 3 clinical study of lecanemab Clarity AD in early AD is ongoing and completed enrollment in March 2021 with a total of 1,795 patients

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