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FDA Accepts Biogen’s BLA for Alzheimer’s Candidate Aducanumab

Biogen (BIIB) said its BLA for aducanumab, the Alzheimer’s disease candidate it is co-developing with Eisai, has been accepted for Priority Review by the FDA with a target action date of March 7, 2021—and a decision expected from the agency even earlier.

The FDA plans to hold an Advisory Committee meeting for the application on a date yet to be set. Biogen said it was told by the agency that it plans to act early on aducanumab under expedited review. Biogen added that it did not use its Priority Review voucher for the aducanumab BLA.

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