Biogen Nabs Speedy FDA Review for Controversial Alzheimer's Drug

Biogen and partner Eisai announced over the weekend that the U.S. Food and Drug Administration (FDA) has accepted its regulatory submission for aducanumab, its once-failed Alzheimer's drug, with priority review, reports FierceBiotech . FDA expects to reach a decision on the medication on March 7, 2021, while Jefferies analyst Michael Yee expects an advisory committee meeting to be held in the first quarter of next year. U.S. law requires companies to demonstrate "substantial" evidence of effectiveness to obtain FDA approval. Aducanumab flunked a utility analysis in March 2019, which led Biogen to terminate its phase 3 program. Eight months later, the company revived the drug, claiming the analysis was "incorrect" as it was based on a smaller dataset that featured fewer patients who received a high dosage. Additional data indicated that aducanumab reduced clinical decline, and Biogen believes if approved, the drug will become the first treatment to slow decline in people with Alzheimer's. Yee wrote in an investor note that Biogen did not use a priority review voucher to secure an expedited review, "suggesting FDA sees this as an unmet need and is willing to review this under an accelerated window."