FDA accepts Alzheimer's candidate aducanumab for priority review

Shares of US biotech major Biogen (Nasdaq: BIIB) rose 12% to $310 in early trading on Friday, after the company announced that the US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease.

Under the priority review, a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021, has been set, and the FDA said that, if possible, it plans to act early on this application under an expedited review. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes. Biogen stated that it did not use its Priority Review voucher and that the status was granted by the FDA on gratis basis.

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement in 2010. Since October 2017, Biogen and Japanese drugmaker Eisai (TYO: 4523) have collaborated on the development and commercialization of aducanumab globally.