Aducanumab

Aducanumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetAmyloid beta
Clinical data
Trade namesAduhelm
Other namesAducanumab-avwa, BIIB037, BIIB-037
AHFS/Drugs.comMonograph
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life24.8 days[2]
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6472H10028N1740O2014S46
Molar mass145912.34 g·mol−1

Aducanumab, sold under the brand name Aduhelm, is a monoclonal antibody designed to treat Alzheimer's disease.[2][3] It is a monoclonal antibody[3][2] that targets aggregated forms (plaque)[4][5] of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup.[6][7] It was developed by Biogen and Eisai.[8] Aducanumab is given via intravenous infusion.[2]

Aducanumab was approved for medical use in the United States by the Food and Drug Administration (FDA) in June 2021,[9] in a controversial decision that led to the resignation of three advisers to the FDA in the absence of evidence that the medication is effective.[10][11][12] The FDA stated that it represents a first-of-its-kind treatment approved for Alzheimer's disease and that it is the first new treatment approved for Alzheimer's since 2003.[3] Aducanumab's approval is controversial for numerous reasons including ambiguous clinical trial results regarding efficacy, the high cost of the medication and the very high rate of serious adverse events.[13][12] The FDA considers it to be a first-in-class medication.[14]

In November 2020, a panel of outside experts for the FDA concluded that a pivotal study of aducanumab failed to show strong evidence that the medication worked, citing questionable efficacy and multiple red flags found with the data analysis.[15] There were also significant health risks associated with the medication; brain swelling or brain bleeding was found in 41% of patients enrolled in the studies.[16] Nevertheless, the medication was approved under the FDA's accelerated approval pathway, and the FDA requires Biogen to perform follow-up reviews to assure the medication is a safe and effective treatment for Alzheimer's disease.[3][17] The Office of Inspector General, US Department of Health and Human Services was asked to investigate interaction between the drug company and the FDA prior to the medication's approval.[18]

Biogen abandoned the drug in January 2024, for financial reasons.[19]

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  2. ^ a b c d e "Aduhelm- aducanumab injection, solution". DailyMed. Archived from the original on 14 June 2021. Retrieved 14 June 2021.
  3. ^ a b c d e "FDA Grants Accelerated Approval for Alzheimer's Drug". U.S. Food and Drug Administration (FDA) (Press release). 7 June 2021. Archived from the original on 8 June 2021. Retrieved 7 June 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ Walsh S, Merrick R, Milne R, Brayne C (July 2021). "Aducanumab for Alzheimer's disease?". BMJ. 374: n1682. doi:10.1136/bmj.n1682. PMC 8258645. PMID 34226181.
  5. ^ Sevigny J, Chiao P, Bussière T, Weinreb PH, Williams L, Maier M, et al. (September 2016). "The antibody aducanumab reduces Aβ plaques in Alzheimer's disease". Nature. 537 (7618): 50–56. Bibcode:2016Natur.537...50S. doi:10.1038/nature19323. PMID 27582220. S2CID 205250312.
  6. ^ Abyadeh M, Gupta V, Gupta V, Chitranshi N, Wu Y, Amirkhani A, et al. (2021). "Comparative Analysis of Aducanumab, Zagotenemab and Pioglitazone as Targeted Treatment Strategies for Alzheimer's Disease". Aging and Disease. 12 (8): 1964–1976. doi:10.14336/AD. PMC 8612603. PMID 34881080.
  7. ^ Toyn J (May 2015). "What lessons can be learned from failed Alzheimer's disease trials?". Expert Review of Clinical Pharmacology. 8 (3): 267–269. doi:10.1586/17512433.2015.1034690. PMID 25860157. S2CID 35158630.
  8. ^ Liu A (15 March 2022). "Biogen takes full control of troubled Aduhelm in revamped Eisai deal". Fierce Pharma. Archived from the original on 21 March 2022. Retrieved 21 March 2022.
  9. ^ "Drug Approval Package: Aduhelm (aducanumab-avwa)". U.S. Food and Drug Administration (FDA). 22 June 2021. Archived from the original on 2 September 2021. Retrieved 1 September 2021.
  10. ^ Mahase E (June 2021). "Three FDA advisory panel members resign over approval of Alzheimer's drug". BMJ. 373: n1503. doi:10.1136/bmj.n1503. PMID 34117086. S2CID 235405355.
  11. ^ Cite error: The named reference NPR resigned was invoked but never defined (see the help page).
  12. ^ a b Cite error: The named reference BelluckThreeResign was invoked but never defined (see the help page).
  13. ^ McGinley L (22 June 2021). "FDA releases fresh details on internal debate over controversial Alzheimer's drug". The Washington Post. Archived from the original on 19 November 2021. Retrieved 24 June 2021.
  14. ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  15. ^ Cite error: The named reference controversy2 was invoked but never defined (see the help page).
  16. ^ Belluck P (22 November 2021). "Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug". The New York Times. ISSN 0362-4331. Archived from the original on 20 July 2022. Retrieved 20 July 2022.
  17. ^ Cite error: The named reference FDA decision was invoked but never defined (see the help page).
  18. ^ Gumbrecht J (9 July 2021). "Acting FDA commissioner calls for independent investigation into approval of Alzheimer's drug". CNN. Archived from the original on 13 August 2021. Retrieved 1 September 2021.
  19. ^ "Biogen will stop selling its controversial Alzheimer's drug Aduhelm". ABC News. Archived from the original on 31 January 2024. Retrieved 1 February 2024.