Biogen Reverses Course on Alzheimer’s Drug Analysis, Plans FDA Filing
Summary
Six months after Biogen stopped work on a closely watched experimental Alzheimer’s disease treatment, the neuroscience drug developer is reviving it with plans to file for FDA approval. Aducanumab’s Phase 3 failure in March was viewed as yet another nail in the coffin for the so-called “amyloid hypothesis”—the theory that by breaking up or clearing the buildup of amyloid protein in the brain, a therapy could stop or even reverse the decline of patients’ memory loss. Howard Fillit, the founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation in New York, says he feels “cautiously optimistic” about Biogen’s new data, but he added that the company has left a number of unanswered questions. Part of a class of drugs called BASE inhibitors, the companies ended the study after independent reviewers concluded that its risks to patients were greater than its benefits. Biogen plans to release more details about its aducanumab analysis in December at the Clinical Trials on Alzheimer’s Disease meeting in San Diego.
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