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FDA approves Alzheimer’s drug lecanemab amid safety concerns
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“Aducanumab has been given FDA approval under the expedited approval pathway to treat moderate AD [134,135,136].”
From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [136]
In the citing paper
“The reduction in amyloid-beta brain plaques, a purported surrogate endpoint that indicates the “progression” of AD, and the encouraging clinical outcomes in one of the two pivotal Phase III trials were two of the factors cited for aducanumab’s expedited approval [130,134,135,136].”
From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [136]
In the citing paper
“Lecanemab (LEQEMBI, brand name), a different monoclonal antibody known as humanized immunoglobulin G1 (IgG1), which specifically targets aggregated forms of amyloid beta, was also given fast approval by the FDA earlier in the year [134,135,136].”
From Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease (2024) · cites this paper as [136]
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“Lecanemab (LEQEMBI, brand name), a different monoclonal antibody known as humanized immunoglobulin G1 (IgG1), which specifically targets aggregated forms of amyloid beta, was also given fast approval by the FDA earlier in the year [134–136].”
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Metadata
- Authors
- Reardon, S.
- Corresponding author
- Reardon, Sara
- Venue
- Nature
- Published
- 2023-01-07
- Volume
- 613
- Issue
- 7943
- Pages
- 227-228
- ISSN
- 0028-0836 (ISSN-L)
- 1476-4687
- OpenAlex
- W4315434323
- Cited by
- 180
- References
- 2
- Citations by year
- 2026: 16 · 2025: 33 · 2024: 66 · 2023: 65
- Type
- other
- Language
- en
- Open access
- closed
- Licence
- Locations
- Nature (publishedVersion)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- 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
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- lecanemab, Alzheimer's disease, drug approval, drug safety, adverse events, anti-amyloid therapy, FDA
- MeSH terms
- Alzheimer Disease, Humans, United States, United States Food and Drug Administration, Drug Approval, Antibodies, Monoclonal, Humanized, Patient Safety
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