Revisiting FDA Approval of Aducanumab
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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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Aducanumab received accelerated approval based on reduction of amyloid plaque as a surrogate endpoint that had not been validated as predicting clinical benefit.
“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]
The FDA granted accelerated approval to aducanumab and stated that reduction of amyloid is reasonably likely to predict clinical benefit.
“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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Chin, N. A., Widera, E., Brangman, S. A., & Karlawish, J. H. (2023) · Journal of the American Geriatrics Society · doi:10.1111/jgs.18652 · Cited by 8 · see citing works
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Self-citationThe Real Question the FDA Is Asking Its Advisory Committees
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PET in neurotherapeutic discovery and development
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Chemical‐Driven Outflow of Dissociated Amyloid Burden from Brain to Blood
Lee, D.-H., Kim, H. V., Kim, H. Y., & Kim, Y. (2022) · Advanced Science · doi:10.1002/advs.202104542 · Cited by 4 · see citing works
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- 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
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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