Biogen (BIIB) and Eisai Announce FDA's 3-Month Extension of Review Period for BLA for Aducanumab

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Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab

January 29, 2021 7:30 AM EST

The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021

CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimers disease. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021.

As part of the ongoing review, Biogen submitted a... More