Biogen and Eisai Co., Ltd. announced that the FDA has extended the review period by three months for the BLA for aducanumab, an investigational treatment for Alzheimer’s disease.

Biogen and Eisai Co., Ltd. announced that the FDA has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021. As part of the ongoing review, Biogen submitted a response to an information request by the FDA, including additional analyses and clinical data, which the FDA considered a Major Amendment to the application that will require additional time for review. An FDA Advisory Committee voted in November 2020 that the treatment was ineffective.