Lecanemab

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(Redirected from BAN2401)

Lecanemab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetBeta amyloid
Clinical data
Trade namesLeqembi
Other namesBAN2401, lecanemab-irmb
License data
Routes of
administration
Intravenous
ATC code
  • None
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][2] Lecanemab is an amyloid beta-directed antibody.[1] It is given via intravenous infusion.[1]

Lecanemab was approved for medical use in the United States in January 2023.[2][3][4]

Medical uses[edit]

Lecanemab is indicated for the treatment of Alzheimer’s disease.[2]

Adverse effects[edit]

Lecanemab may cause amyloid-related imaging abnormalities.[2]

Mode of action[edit]

Lecanemab is a monoclonal antibody consisting of the humanized version[5] of a mouse antibody, mAb158, that recognizes protofibrils and prevents amyloid beta deposition in animal models of Alzheimer's disease.[6]

History[edit]

In July 2022, the US Food and Drug Administration (FDA) accepted an application for accelerated approval for lecanemab and granted it priority review designation.[7]

In September 2022, Biogen announced[7][8] positive results from an ongoing phase III clinical trial.[9][10]

In November 2022, it was announced that the drug was a success in clinical trials, and exceeded its goal in reaching primary endpoints.[11]

The efficacy of lecanemab was evaluated in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 participants with Alzheimer's disease.[2] Treatment was initiated in participants with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology.[2] 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.[2] 

Society and culture[edit]

Legal status[edit]

In January 2023, the FDA granted accelerated approval for lecanemab.[2][12] The FDA granted the application for lecanemab fast track, priority review, and breakthrough therapy designations.[2] The approval of Leqembi was granted to Eisai R&D Management Co., Ltd.[2]

Economics[edit]

Lecanemab pricing is US$26,500 per year.[13]

Names[edit]

Lecanemab is the international nonproprietary name.[14]

Research[edit]

It was jointly developed by the companies Eisai and Biogen 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[edit]

  1. ^ a b c d "Leqembi- lecanemab injection, solution". DailyMed. 11 January 2023. Retrieved 21 January 2023.
  2. ^ a b c d e f g h i j "FDA Grants Accelerated Approval for Alzheimer's Disease Treatment" (Press release). U.S. Food and Drug Administration (FDA). 6 January 2023. Retrieved 7 January 2023.
  3. ^ "Lecanemab Summary Review" (PDF). Center for Drug Evaluation and Research (CDER). U.S. Food and Drug Administration. Archived (PDF) from the original on 7 January 2023. Retrieved 7 January 2023.
  4. ^ "FDA Approves Leqembi (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease" (Press release). Eisai Inc. 6 January 2023. Retrieved 7 January 2023 – via PR Newswire.
  5. ^ 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.
  6. ^ 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.
  7. ^ a b "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. Retrieved 28 September 2022.
  8. ^ Robbins R, Belluck P (27 September 2022). "Alzheimer's Drug Slows Cognitive Decline in Key Study". The New York Times. Retrieved 28 September 2022.
  9. ^ "A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD)". ClinicalTrials.gov. 11 July 2022. Retrieved 28 September 2022.
  10. ^ "'This looks like the real deal': Are we inching closer to a treatment for Alzheimer's?". The Guardian. 22 November 2022.
  11. ^ "Alzheimer's drug lecanemab hailed as momentous breakthrough". Archived from the original on 2 December 2022. Retrieved 30 November 2022.
  12. ^ Howard J (6 January 2023). "Alzheimer's drug lecanemab receives accelerated approval amid safety concerns". CNN. Retrieved 6 January 2023.
  13. ^ "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. Retrieved 7 January 2023 – via PR Newswire.
  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[edit]

External links[edit]