Aducanumab: A fate undecided

Few drug development tales have had the twists and turns of aducanumab , Biogen’s antibody treatment for Alzheimer’s disease. And as 2020 comes to a close, Biogen’s highly anticipated drug sits under a dangling sword. In a November hearing with a US Food and Drug Administration advisory panel, the agency’s statisticians panned the company’s analysis of clinical data, and external reviewers seemed unconvinced the drug is effective. The FDA has until March 2021 to make a ruling. This latest chapter comes after a tumultuous year and a half for aducanumab, which binds to protein fragments called amyloid-β that accumulate in the brains of people with Alzheimer’s. Biogen halted Phase 3 trials of the treatment in early 2019 after an independent data monitoring committee said the drug was unlikely to prove effective. The company turned around a few months later and applied for FDA approval based on a larger data set—one