Revisiting FDA Approval of Aducanumab

Affiliations

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.).

G Caleb Alexander et al. N Engl J Med. 2021.

. 2021 Aug 26;385(9):769-771.

doi: 10.1056/NEJMp2110468. Epub 2021 Jul 28.

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.).

No abstract available

Comment in

An Appropriate Use of Accelerated Approval - Aducanumab for Alzheimer's Disease.
Dunn B, Stein P, Temple R, Cavazzoni P. Dunn B, et al. N Engl J Med. 2021 Aug 26;385(9):856-857. doi: 10.1056/NEJMc2111960. Epub 2021 Jul 28. N Engl J Med. 2021. PMID: 34320283 No abstract available.

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