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.[3][4] Lecanemab is an amyloid beta-directed antibody.[3] It is given via intravenous infusion to patients with mild cognitive impairment or mild dementia.[3] In clinical trials, it demonstrated modest efficacy in reducing relative cognitive decline compared to placebo.[5] 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.[6]

Lecanemab was jointly developed by Eisai and Biogen. It was granted accelerated approval for medical use in the United States in January 2023,[7] and fully approved by the FDA in July 2023.[4][8] Lecanemab was priced at $26,500 per year in the United States.[9] The European Medicines Agency ruled against approving the drug.[10] In Great Britain, the drug was approved but will not be covered by the English NHS due to its unfavorable benefit–cost ratio.

  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. ^ "Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024". Federal Register of Legislation. 30 May 2024. Archived from the original on 10 June 2024. Retrieved 10 June 2024.
  3. ^ a b c d "Leqembi – lecanemab injection, solution". DailyMed. 11 January 2023. Archived from the original on 15 January 2023. Retrieved 21 January 2023.
  4. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ Kwon D (22 August 2024). "Debate rages over Alzheimer's drug lecanemab as UK limits approval". Nature. doi:10.1038/d41586-024-02720-y.
  6. ^ Cite error: The named reference FDA PR 20230706 was invoked but never defined (see the help page).
  7. ^ "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.
  8. ^ "Lecanemab Summary Review" (PDF). Center for Drug Evaluation and Research (CDER). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on 7 January 2023. Retrieved 7 January 2023.
  9. ^ "EISAI'S APPROACH TO U.S. PRICING FOR LEQEMBI™ (LECANEMAB), A TREATMENT FOR EARLY ALZHEIMER'S DISEASE, SETS FORTH OUR CONCEPT OF "SOCIETAL VALUE OF MEDICINE" IN RELATION TO "PRICE OF MEDICINE" | News Release：2023". Eisai Co., Ltd. Retrieved 19 September 2024.
  10. ^ "First drug to slow Alzheimer's too costly for NHS". 22 August 2024.