In Reversal, Biogen to Submit Experimental Alzheimer's Drug for Approval

Biogen has surprisingly announced plans to submit an Alzheimer's drug that the company previously dismissed as a failure for U.S. Food and Drug Administration approval, reports STAT . The drugmaker claims a "new analysis of a larger dataset" showed that the experimental medication, aducanumab, reduced clinical decline in subjects with early Alzheimer's on multiple effectiveness measures. This counters Biogen's March decision to discontinue studies of the treatment, based on the recommendation of an independent monitoring board. Included in the new analysis is additional data that became available after earlier evaluation designated the trials as "futile." Biogen said the new data indicates aducanumab to be "pharmacologically and clinically active," and that its further reduction of clinical decline is founded on the results of the Clinical Dementia Rating-Sum of Boxes survey. "We are hopeful about the prospect of offering . . . the first therapy to reduce the clinical decline of Alzheimer's disease and the potential implication of these results for similar approaches targeting amyloid beta," said Biogen CEO Michel Vounatsos.