Controversy and Progress in Alzheimer’s Disease — FDA Approval of Aducanumab
Abstract
Interview with Dr. Gil Rabinovici on the FDA’s controversial approval of a new treatment for Alzheimer’s disease. (16:39)Download The FDA’s accelerated approval of aducanumab represents a landmark moment, though the drug’s road to the clinic has been rocky and contentious. The hope is that despite its limitations, this first-in-class drug will open the door to more efficacious therapies.
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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 [104]
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References 4 · Cited by 155
- Authors
- Rabinovici, G. D.
- Affiliations
- University of California, San Francisco (US)
- Corresponding author
- Rabinovici, Gil D.
- ORCID
- Rabinovici, Gil D.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-08-26
- Volume
- 385
- Issue
- 9
- Pages
- 771-774
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3186275776
- Cited by
- 155
- References
- 4
- Citations by year
- 2026: 12 · 2025: 28 · 2024: 22 · 2023: 34 · 2022: 43 · 2021: 16
- FWCI
- 18.07
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
- Keywords
- Alzheimer's disease, aducanumab, accelerated FDA approval, amyloid-beta, anti-amyloid therapy, first-in-class drugs
- MeSH terms
- Alzheimer Disease, Drug Industry, Humans, Interprofessional Relations, Time Factors, United States, United States Food and Drug Administration, Biomarkers, Amyloid beta-Peptides, Drug Approval, Positron-Emission Tomography, Plaque, Amyloid, Antibodies, Monoclonal, Humanized
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