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Revisiting FDA Approval of Aducanumab
Open accessAbstract
Interview with Dr. Gil Rabinovici on the FDA’s controversial approval of a new treatment for Alzheimer’s disease. (16:39)Download 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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“This decision was based on the effects of aducanumab on the surrogate endpoint of reduction of amyloid plaque in the brain of patients with AD, which at that point was not validated as being predictive of clinical benefit”
From The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics (2022) · cites this paper as [9]
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“The FDA has controversially granted accelerated approval to aducanumab and has opined that the reduction of amyloid is reasonably likely to predict clinical benefit 7,9,[98][99][100][101][102][103][104][105][106][107] .”
From The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics (2022) · cites this paper as [9]
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Metadata
- Authors
- Alexander, G. C., Knopman, D. S., Emerson, S. S., Ovbiagele, B., Kryscio, R. J., Perlmutter, J. S., & Kesselheim, A. S.
- Affiliations
- Brigham and Women's Hospital (US)
- Mayo Clinic (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-08-26
- Volume
- 385
- Issue
- 9
- Pages
- 769-771
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC11694499
- OpenAlex
- W3185118626
- Cited by
- 162
- References
- 1
- Citations by year
- 2026: 10 · 2025: 19 · 2024: 33 · 2023: 36 · 2022: 48 · 2021: 16
- FWCI
- 20.86
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Neurological Disorders and Stroke (RF1NS075321, R01NS103957, R01NS107281, R01NS075321)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Keywords
- aducanumab, FDA drug approval, Alzheimer's disease, amyloid-beta, surrogate endpoints, accelerated approval, anti-amyloid therapy, regulatory decision-making
- MeSH terms
- Alzheimer Disease, Humans, Time Factors, United States, United States Food and Drug Administration, Biomarkers, Amyloid beta-Peptides, Drug Approval, Advisory Committees, Plaque, Amyloid, Antibodies, Monoclonal, Humanized
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