Revisiting FDA Approval of Aducanumab

G Caleb Alexander¹, David S Knopman¹, Scott S Emerson¹+4

• ¹From the Center for Drug Safety and Effectiveness and the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore (G.C.A.); the Department of Neurology, Mayo Clinic, Rochester, MN (D.S.K.); the Department of Biostatistics, University of Washington, Seattle (S.S.E.); the Department of Neurology, University of California, San Francisco (B.O.); the Bin Zhang Department of Statistics and the Sanders Brown Center on Aging, University of Kentucky, Lexington (R.J.K.); the Departments of Neurology, Radiology, Neuroscience, Physical Therapy, and Occupational Therapy, Washington University, St. Louis (J.S.P.); the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School - both in Boston (A.S.K.).