FDA delays review of Alzheimer's candidate aducanumab
US biotech Biogen (Nasdaq: BIIB) and Japanese partner Eisai (TYO: 4523) today announced that the US Food and Drug Administration has extended the review period by three months for their 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.
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