Lecanemab

Lecanemab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetAmyloid beta
Clinical data
Trade namesLeqembi
Other namesBAN2401, lecanemab-irmb
AHFS/Drugs.comMonograph
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6544H10088N1744O2032S46
Molar mass147181.62 g·mol−1

Lecanemab, sold under the brand name Leqembi, is a monoclonal antibody medication used for the treatment of Alzheimer's disease.[1][5] Lecanemab is an amyloid beta-directed antibody.[1] It is given via intravenous infusion to patients with mild cognitive impairment or mild dementia.[1] In clinical trials, it demonstrated modest efficacy in reducing relative cognitive decline compared to placebo.[6] The most common side effects of lecanemab include headache, infusion-related reactions, and amyloid-related imaging abnormalities, a side effect known to occur with the class of antibodies targeting amyloid.[7]

Lecanemab was jointly developed by Eisai, Biogen and BioArctic.[8] It was granted accelerated approval for medical use in the United States in January 2023,[9] and fully approved by the FDA in July 2023.[5][10] Lecanemab was approved for medical use in South Korea in May 2024,[11] and in Mexico in December 2024.[12]

  1. ^ a b c d "Leqembi – lecanemab injection, solution". DailyMed. 11 January 2023. Archived from the original on 15 January 2023. Retrieved 21 January 2023.
  2. ^ Cite error: The named reference Leqembi EPAR was invoked but never defined (see the help page).
  3. ^ Cite error: The named reference Leqembi PI was invoked but never defined (see the help page).
  4. ^ "Update on Regulatory Review of Lecanemab for Early Alzheimer's Disease in Australia". Biogen (Press release). 16 October 2024. Retrieved 14 November 2024.
  5. ^ a b "FDA Grants Accelerated Approval for Alzheimer's Disease Treatment" (Press release). U.S. Food and Drug Administration (FDA). 6 January 2023. Archived from the original on 7 January 2023. Retrieved 7 January 2023. This article incorporates text from this source, which is in the public domain.
  6. ^ Kwon D (August 2024). "Debate rages over Alzheimer's drug lecanemab as UK limits approval". Nature. doi:10.1038/d41586-024-02720-y. PMID 39179772.
  7. ^ Cite error: The named reference FDA PR 20230706 was invoked but never defined (see the help page).
  8. ^ Lannfelt P. "Utveckling av sjukdomsmodifierande behandlingar mot Alzheimers sjukdom". bioarctic.com. bioarctic. Retrieved 21 April 2025.
  9. ^ "Drug Approval Package: Leqembi". U.S. Food and Drug Administration (FDA). 6 February 2023. Archived from the original on 9 July 2023. Retrieved 8 July 2023.
  10. ^ "Lecanemab Summary Review" (PDF). Center for Drug Evaluation and Research (CDER). U.S. Food and Drug Administration (FDA). Archived from the original (PDF) on 7 January 2023. Retrieved 7 January 2023.
  11. ^ "Leqembi launched in South Korea" (Press release). BioArctic. 27 November 2024. Retrieved 6 December 2024 – via PR Newswire.
  12. ^ "Leqembi approved in Mexico" (Press release). BioArctic. 4 December 2024. Retrieved 6 December 2024 – via PR Newswire.
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