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.

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Bibliographische Detailangaben
Veröffentlicht in:	The New England journal of medicine 2021-08, Vol.385 (9), p.769-771
Hauptverfasser:	Alexander, G. Caleb, Knopman, David S, Emerson, Scott S, Ovbiagele, Bruce, Kryscio, Richard J, Perlmutter, Joel S, Kesselheim, Aaron S
Format:	Artikel
Sprache:	eng
Schlagworte:	Advisory Committees Aging Alzheimer Disease Alzheimer Disease - drug therapy Alzheimer's disease Amyloid beta-Peptides - antagonists & inhibitors and the FDA Antibodies, Monoclonal, Humanized - therapeutic use Biomarkers Brain research Clinical trials Cognitive ability Committees Dementia Devices Drug Approval Drug dosages Drugs FDA approval General & Internal Medicine Geriatrics Health Policy Humans Hypotheses Life Sciences & Biomedicine Medicine, General & Internal Monoclonal antibodies Neurodegenerative diseases Neurology Neurosurgery Plaque, Amyloid - drug therapy Science & Technology Time Factors United States United States Food and Drug Administration β-Amyloid
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Beschreibung
Zusammenfassung:	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.
ISSN:	0028-4793 1533-4406 1533-4406
DOI:	10.1056/NEJMp2110468