Lecanemab: Difference between revisions
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== Further reading == |
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* {{cite journal | vauthors = Tolar M, Abushakra S, Hey JA, Porsteinsson A, Sabbagh M | title = Aducanumab, gantenerumab, BAN2401, and ALZ-801-the first wave of amyloid-targeting drugs for Alzheimer's disease with potential for near term approval | journal = Alzheimer's Research & Therapy | volume = 12 | issue = 1 | pages = 95 | date = August 2020 | pmid = 32787971 | pmc = 7424995 | doi = 10.1186/s13195-020-00663-w }} |
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== External links == |
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{{Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems}} |
{{Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems}} |
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{{Portal bar | Medicine}} |
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Revision as of 00:33, 7 January 2023
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Beta amyloid |
| Clinical data | |
| Trade names | Leqembi |
| Other names | BAN2401, lecanemab-irmb |
| License data | |
| Routes of administration | Intravenous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6544H10088N1744O2032S46 |
| Molar mass | 147181.62 g·mol−1 |
Lecanemab, sold under the brand name Leqembi, is a monoclonal antibody medication used for the treatment of Alzheimer's disease.[2][3] Lecanemab is an amyloid beta-directed antibody.[2] It is given via intravenous infusion.[2]
Lecanemab was approved for medical use in the United States in January 2023.[3][4][5]
Medical uses
Lecanemab is indicated for the treatment of Alzheimer’s disease.[3]
Adverse effects
Lecanemab may cause amyloid-related imaging abnormalities.[3]
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.[3] Treatment was initiated in participants with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology.[3] 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.[3]
In January 2023, the FDA granted accelerated approval for lecanemab.[3][13] The FDA granted the application for lecanemab fast track, priority review, and breakthrough therapy designations.[3] The approval of Leqembi was granted to Eisai R&D Management Co., Ltd.[3]
Research
It was jointly developed by the companies Biogen and Eisai and is in clinical trials for the treatment of Alzheimer's disease.[14]
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.[15]
References
- ^ "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.
- ^ a b c d https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s000lbl.pdf
- ^ a b c d e f g h i j "FDA Grants Accelerated Approval for Alzheimer's Disease Treatment". U.S. Food and Drug Administration (FDA) (Press release). 6 January 2023. Retrieved 7 January 2023.
- ^ https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2023/761269Orig1s000SumR.pdf
- ^ "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.
- ^ Lannfelt L, Möller C, Basun H, Osswald G, Sehlin D, Satlin A, Logovinsky V, Gellerfors P (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.
{{cite journal}}: CS1 maint: unflagged free DOI (link) - ^ Söllvander S, Nikitidou E, Gallasch L, Zyśk M, Söderberg L, Sehlin D, Lannfelt L, Erlandsson A (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.
{{cite journal}}: CS1 maint: unflagged free DOI (link) - ^ 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.
- ^ Robbins R, Belluck P (27 September 2022). "Alzheimer's Drug Slows Cognitive Decline in Key Study". The New York Times. Retrieved 28 September 2022.
- ^ "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.
- ^ "'This looks like the real deal': Are we inching closer to a treatment for Alzheimer's?". The Guardian. 22 November 2022.
- ^ "Alzheimer's drug lecanemab hailed as momentous breakthrough". Archived from the original on 2 December 2022. Retrieved 30 November 2022.
- ^ Howard, Jacqueline (6 January 2023). "Alzheimer's drug lecanemab receives accelerated approval amid safety concerns". CNN. Retrieved 6 January 2023.
- ^ Clinical trial number NCT01767311 for "Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease" at ClinicalTrials.gov
- ^ 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
- Tolar M, Abushakra S, Hey JA, Porsteinsson A, Sabbagh M (August 2020). "Aducanumab, gantenerumab, BAN2401, and ALZ-801-the first wave of amyloid-targeting drugs for Alzheimer's disease with potential for near term approval". Alzheimer's Research & Therapy. 12 (1): 95. doi:10.1186/s13195-020-00663-w. PMC 7424995. PMID 32787971.
{{cite journal}}: CS1 maint: unflagged free DOI (link)
