Lecanemab

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Lecanemab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetBeta amyloid
Names
Trade namesLeqembi
Other namesBAN2401, lecanemab-irmb
Clinical data
Main usesAlzheimer disease[1]
Side effectsHeadache, infusion reactions, brain swelling[1]
Routes of
use
Intravenous
Typical dose10 mg/kg q 2 wks[1]
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
Chemical and physical data
FormulaC6544H10088N1744O2032S46
Molar mass147181.62 g·mol−1

Lecanemab, sold under the brand name Leqembi, is a medication used to treat Alzheimer disease.[1] It is used in those with mild disease, were it has been shown to reduce amyloid plaque.[1] It is given by gradual injection into a vein.[1]

Common side effects include headache, infusion reactions, and brain swelling.[1] Other side effects may include amyloid related imaging abnormalities (ARIA).[1] It is a monoclonal antibody that attaches to amyloid beta.[1]

Lecanemab was approved for medical use in the United States in 2023.[1] In 2023 the manufacturer submitted a request for approval in Europe.[3] It is to cost about US$26,500 per year for a 75 kg person.[4]

Medical uses

Lecanemab is indicated for the treatment of Alzheimer disease.[5]

Dosage

It is given at a dose of 10 mg/kg over about an hour every two weeks.[1]

Side effects

Lecanemab may cause amyloid related imaging abnormalities (ARIA).[5]

Mode of action

Lecanemab is a monoclonal antibody consisting of the humanized version[6] of a mouse antibody, mAb158, that recognizes protofibrils and prevents amyloid beta deposition in animal models of Alzheimer's disease.[7]

History

In July 2022, the US Food and Drug Administration (FDA) accepted an application for accelerated approval for lecanemab and granted it priority review designation.[8]

In September 2022, Biogen announced[8][9] positive results from an ongoing phase III clinical trial.[10][11]

In November 2022, it was announced that the drug was a success in clinical trials, and exceeded its goal in reaching primary endpoints.[12]

The efficacy of lecanemab was evaluated in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 participants with Alzheimer's disease.[5] Treatment was initiated in participants with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology.[5] Participants receiving the treatment had significant dose- and time-dependent reduction of amyloid beta plaque, with participants receiving the approved dose of lecanemab, 10 milligram/kilogram every two weeks, having a statistically significant reduction in brain amyloid plaque from baseline to week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque.[5] 

Society and culture

Legal status

In January 2023, the FDA granted accelerated approval for lecanemab.[5][13] The FDA granted the application for lecanemab fast track, priority review, and breakthrough therapy designations.[5] The approval of Leqembi was granted to Eisai R&D Management Co., Ltd.[5]

Economics

Lecanemab pricing is US$26,500 per year.[4]

Names

Lecanemab is the international nonproprietary name.[14]

Research

It was jointly developed by the companies Biogen and Eisai and is in clinical trials for the treatment of Alzheimer's disease.[15]

It has shown statistically significant but minor progress, with studies suggesting a decrease in cognitive decline in Alzheimer's participants compared with a control group given a placebo instead.[16]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 "DailyMed - LEQEMBI- lecanemab injection, solution". dailymed.nlm.nih.gov. Archived from the original on 15 January 2023. Retrieved 12 January 2023.
  2. "Leqembi (lecanemab-irmb) injection, for intravenous use Initial U.S. Approval: 2023" (PDF). Eisai Inc. January 2023. Archived (PDF) from the original on 7 January 2023. Retrieved 7 January 2023.
  3. "Eisai submits MAA for lecanemab in Europe". European Pharmaceutical Review. Archived from the original on 11 January 2023. Retrieved 12 January 2023.
  4. 4.0 4.1 "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"" (Press release). Eisai Inc. 6 January 2023. Archived from the original on 7 January 2023. Retrieved 7 January 2023 – via PR Newswire.
  5. 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 "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.
  6. Lannfelt L, Möller C, Basun H, Osswald G, Sehlin D, Satlin A, et al. (2014). "Perspectives on future Alzheimer therapies: amyloid-β protofibrils - a new target for immunotherapy with BAN2401 in Alzheimer's disease". Alzheimer's Research & Therapy. 6 (2): 16. doi:10.1186/alzrt246. PMC 4054967. PMID 25031633.
  7. Söllvander S, Nikitidou E, Gallasch L, Zyśk M, Söderberg L, Sehlin D, et al. (March 2018). "The Aβ protofibril selective antibody mAb158 prevents accumulation of Aβ in astrocytes and rescues neurons from Aβ-induced cell death". Journal of Neuroinflammation. 15 (1): 98. doi:10.1186/s12974-018-1134-4. PMC 5875007. PMID 29592816.
  8. 8.0 8.1 "Lecanemab Confirmatory Phase 3 Clarity Ad Study Met Primary Endpoint, Showing Highly Statistically Significant Reduction of Clinical Decline in Large Global Clinical Study of 1,795 Participants With Early Alzheimer's Disease" (Press release). Biogen. 27 September 2022. Archived from the original on 27 September 2022. Retrieved 28 September 2022.
  9. Robbins R, Belluck P (27 September 2022). "Alzheimer's Drug Slows Cognitive Decline in Key Study". The New York Times. Archived from the original on 28 September 2022. Retrieved 28 September 2022.
  10. "A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD)". ClinicalTrials.gov. 11 July 2022. Archived from the original on 28 September 2022. Retrieved 28 September 2022.
  11. "'This looks like the real deal': Are we inching closer to a treatment for Alzheimer's?". The Guardian. 22 November 2022. Archived from the original on 10 January 2023. Retrieved 10 January 2023.
  12. "Alzheimer's drug lecanemab hailed as momentous breakthrough". Archived from the original on 2 December 2022. Retrieved 30 November 2022.
  13. Howard J (6 January 2023). "Alzheimer's drug lecanemab receives accelerated approval amid safety concerns". CNN. Archived from the original on 6 January 2023. Retrieved 6 January 2023.
  14. World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
  15. Clinical trial number NCT01767311 for "Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease" at ClinicalTrials.gov
  16. Devlin H (28 September 2022). "Success of experimental Alzheimer's drug hailed as 'historic moment'". The Guardian. Archived from the original on 28 September 2022.

Further reading

External links

Identifiers: