Content area
Abstract
Revisiting FDA Approval of Aducanumab
Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, it’s essential to consider beta-amyloid’s suitability as a surrogate end point. Doing so casts doubt on the wisdom of the decision.
Details
Title
Revisiting FDA Approval of Aducanumab
Author
Alexander, G Caleb; Knopman, David S; Emerson, Scott S; Ovbiagele, Bruce; Kryscio, Richard J; Perlmutter, Joel S; Kesselheim, Aaron S 1
1 From 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.).
1 From 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.).
Pages
769-771
Section
Perspective
Publication year
2021
Publication date
Aug 26, 2021
Website
ISSN
00284793
e-ISSN
15334406
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2564516153
Copyright
Copyright © 2021 Massachusetts Medical Society. All rights reserved.