Rolling submission to the FDA of BLA for lecanemab for early Alzheimer's disease is completed under accelerated approval pathway.
Eisai Co., Ltd. and Biogen Inc. announced that Eisai has completed the rolling submission to the FDA of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (A) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.
As part of the completed rolling submission, Eisai has requested Priority Review. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase III confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during fiscal year 2022.
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