FDA approves second anti-amyloid antibody for Alzheimer disease
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Lecanemab is a humanized IgG1 monoclonal antibody specifically targeting aggregated forms of amyloid beta and was given fast approval by the FDA.
“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 [135]
Aducanumab was given FDA approval under the expedited approval pathway to treat moderate AD.
“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 [135]
Reduction in amyloid-beta brain plaques and encouraging clinical outcomes in one of two pivotal Phase III trials were factors cited for aducanumab's expedited approval.
“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 [135]
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Recent Advances in Therapeutics for the Treatment of Alzheimer’s Disease
Thawabteh, A. M., Ghanem, A. W., AbuMadi, S., Thaher, D., Jaghama, W., Karaman, D., & Karaman, R. (2024) · Molecules · doi:10.3390/molecules29215131 · Cited by 56 · see citing works
Lorenzo, D. D. (2024) · ChemMedChem · doi:10.1002/cmdc.202400180 · Cited by 40 · see citing works
Tobeh, N. S., & Bruce, K. D. (2023) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2023.1259012 · Cited by 31 · see citing works
“However, despite these concerning statistics, there are currently no FDA-approved therapies that can Tobeh and Bruce 10.3389/fnagi.2023.1259012 Frontiers in Aging Neuroscience 02 frontiersin.org (Hickman et al., 2008), and lipid droplet (LD) accumulation in microglia (Farmer et al., 2020).”
BackgroundInfluentialHaage, V. C., Tuddenham, J. F., Comandante-Lou, N., Bautista, A. R., Monzel, A. S., Chiu, R., Fujita, M., Garcia, F. G., Bhattarai, P., Patel, R., et al. (2024) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2024.02.06.579103 · Cited by 15 · see citing works
Alzheimer's Disease: Status of Low‐Dimensional Nanotherapeutic Materials
Huang, D., Liao, W., Li, J., Chen, T., Wang, X., Zhao, R., Zhang, L., Yu, X., Zheng, D., & Luan, P. (2023) · Advanced Functional Materials · doi:10.1002/adfm.202302015 · Cited by 14 · see citing works
Lorenzo, D. D., Bisi, N., Kaffy, J., Ramirez, L., Zweckstetter, M., Lequin, O., Garfagnini, I., Luo, J., Hannappel, Y., Ennen, I., et al. (2024) · bioRxiv · doi:10.1038/s41467-025-63824-1 · Cited by 12 · see citing works
“Despite their controversial utility and high cost, three antibodies targeting A β 1-42 , Aducanumab (FDA approval in June 2021), Lecanemab (approved in July 2023 by the FDA and inNovember 2024 by the EMA) 12 , and Donanemab (FDA approval in July 2024) 13 , have recently arrived on the market, ushering in the last thre…”
Li, W., Rang, Y., Liu, H., & Liu, C. (2023) · Phytotherapy Research · doi:10.1002/ptr.7908 · Cited by 8 · see citing works
Patil, S. P., Kuehn, B. R., McCullough, C., Bates, D., Hazim, H., Diallo, M., & Francois, N. (2025) · Molecules · doi:10.3390/molecules30040940 · Cited by 9 · see citing works
“In this context, two anti-A β monoclonal antibodies, viz., Aducanumab and Lecanemab, have recently received accelerated approvals by the United States Food and Drug Administration (FDA) [11,12].”
Silver nanoparticles alter the dimerization of Aβ 42 studied by REMD simulations
Thai, Q. M., Tran, P., Phùng, H. T. T., et al. (2024) · RSC Advances · doi:10.1039/d4ra02197e · Cited by 7 · see citing works
Patil, S. P., & Kuehn, B. R. (2024) · Pharmaceuticals · doi:10.3390/ph17040491 · Cited by 5 · see citing works
“…recently received accelerated approvals by the United States Food and Drug Administration (FDA), viz. aducanumab (June 2021), and lecanemab (January 2023), Pharmaceuticals 2024 , 17 , 491 2 of 15 with the latter receiving full FDA approval in July 2023 owing to its compelling clinical data [8,9].”
BackgroundThe association of microbial infection and adaptive immune cell activation in Alzheimer’s disease
Clement, M. (2023) · Discovery Immunology · doi:10.1093/discim/kyad015 · Cited by 6 · see citing works
“There is no current cure for AD, but recent exciting advances have been made that focus on new immunotherapy-based anti-A β antibody treatments [5, 6].”
BackgroundRui, X., Zhao, X. O., Zhang, N., Ding, Y., Seki, C., Ono, M., Higuchi, M., Zhang, M., Chu, Y., Wei, R., et al. (2024) · NeuroImage · doi:10.1016/j.neuroimage.2024.120947 · Cited by 4 · see citing works
Pre-Diagnosis Observational and Prescription History Associated with Alzheimer’s Disease IncidencePreprint
Williams, G. H. (2024) · medRxiv · doi:10.1101/2024.07.17.24310553 · Cited by 3 · see citing works
“With the exception of the controversial approval for AD of the at best moderately effective anti-amyloid antibody therapies[1-4], with aducanumab being recently discontinued due to cost and side effect issues[5], there have been no new AD therapeutics coming to market in over 20 years.”
BackgroundPatil, S. P., Kuehn, B. R., McCullough, C., et al. (2025) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2025.01.03.631209 · Cited by 2 · see citing works
“If You Change the Way You Look at Things, Things You Look at Change”
Behl, C. (2023) · Springer eBooks · doi:10.1007/978-3-031-31570-1_21 · Cited by 1 · see citing works
Haage, V. C., Tuddenham, J. F., Comandante-Lou, N., Bautista, A. R., Monzel, A. S., Chiu, R., Fujita, M., Garcia, F. G., Bhattarai, P., Patel, R., et al. (2024) · SSRN Electronic Journal · doi:10.2139/ssrn.4755485
Behl, C. (2026) · Springer eBooks · doi:10.1007/978-3-662-72210-7_21
Haage, V. C., Tuddenham, J. F., Comandante-Lou, N., Bautista, A. R., Monzel, A. S., Garcia, F. G., Chiu, R., Fujita, M., Bhattarai, P., White, C. C., et al. (2026) · Cell Reports · doi:10.1016/j.celrep.2026.118031
- Authors
- Mullard, A.
- Corresponding author
- Mullard, Asher
- Venue
- Nature Reviews Drug Discovery
- Published
- 2023-01-09
- Volume
- 22
- Issue
- 2
- Pages
- 89-89
- ISSN
- 1474-1776 (ISSN-L)
- 1474-1784
- OpenAlex
- W4313893453
- Cited by
- 19
- References
- 0
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 8 · 2023: 7
- FWCI
- 3.38
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Nature Reviews Drug Discovery (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
- Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
- Keywords
- Alzheimer's disease, anti-amyloid antibodies, amyloid-beta, drug approval, anti-amyloid therapy, monoclonal antibodies
- MeSH terms
- Alzheimer Disease, Humans, United States, United States Food and Drug Administration, Drug Approval
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