The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for aducanumab (Biogen) for the treatment of Alzheimer disease.

Aducanumab is an investigational human monoclonal antibody that targets amyloid beta and is administered as a monthly intravenous infusion. If approved, the drug would become the first therapy to slow cognitive and functional decline in patients with early Alzheimer disease, according to Biogen. It would also be the first drug to demonstrate that reducing amyloid beta in the brain results in better clinical outcomes in these patients.

The BLA submission includes data from the phase 3 EMERGE study, which enrolled 1638 adults aged 50 to 85 years with early Alzheimer disease. Results showed that aducanumab high dose met the primary end point achieving a statistically significant reduction of 22% in Clinical Dementia Rating-Sum of Boxes (CDR-SB) scores at week 78 vs placebo (P =.01). While the phase 3 ENGAGE study, also included in the BLA, did not meet its primary end point, Biogen noted that a subset of the data appeared to support the outcome in the EMERGE study.

“The FDA’s acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease.”

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A Prescription Drug User Fee Act (PDUFA) target date of March 7, 2021 has been set for this application.

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FDA accepts Biogen’s aducanumab Biologics License Application for Alzheimer’s disease with Priority Review. Accessed August 9, 2020.