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Mavacamten

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Mavacamten
Clinical data
Trade namesCamzyos
Other namesMYK-461
AHFS/Drugs.comMonograph
MedlinePlusa622047
License data
Pregnancy
category
Routes of
administration		By mouth
Drug classCardiac myosin inhibitor
ATC code
Legal status
Legal status
Identifiers
  • 6-[[(1S)-1-phenylethyl]amino]-3-propan-2-yl-1H-pyrimidine-2,4-dione
CAS Number
PubChem CID
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC15H19N3O2
Molar mass273.336 g·mol−1
3D model (JSmol)
  • CC(C)N1C(=O)NC(N[C@@H](C)C2=CC=CC=C2)=CC1=O
  • InChI=1S/C15H19N3O2/c1-10(2)18-14(19)9-13(17-15(18)20)16-11(3)12-7-5-4-6-8-12/h4-11,16H,1-3H3,(H,17,20)/t11-/m0/s1
  • Key:RLCLASQCAPXVLM-NSHDSACASA-N

Mavacamten, sold under the brand name Camzyos, is a medication used to treat obstructive hypertrophic cardiomyopathy.[8][9]

Mavacamten is a small-molecule allosteric [10] and cardiac myosin inhibitor.[8] It was developed by MyoKardia, a subsidiary of Bristol Myers Squibb.[11] In clinical studies, mavacamten has demonstrated significant efficacy in reducing cardiac muscle contractility by targeting the sarcomere hypercontractility that is one of the characteristics of hypertrophic cardiomyopathy and inhibits excessive myosin actin cross-bridge formation, shifting the overall myosin population towards an energy-sparing, recruitable, super-relaxed state.[8]

Mavacamten was approved for medical use in the United States in April 2022.[8][12][13][14] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[15][16]

Medical uses

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Mavacamten is indicated for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.[8]

Adverse effects

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The US prescribing information for mavacamten contains a boxed warning regarding heart failure. Mavacamten reduces the left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.[8]

History

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Mavacamten was granted orphan drug designation by the US Food and Drug Administration (FDA).[17]

Society and culture

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[edit]

On 26 April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Camzyos, intended for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).[18] The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[18] In June 2023, the European Commission approved Mavacamten.[9][19][20]

Mavacamten is approved for use in the US,[21] Canada,[22] Australia,[23] South Korea,[24] Singapore,[25] Switzerland,[26] Brazil[27] and Macau.[28]

Names

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Mavacamten is the international nonproprietary name (INN).[29]

References

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  1. ^ a b "Camzyos". Therapeutic Goods Administration (TGA). 13 October 2022. Archived from the original on 5 February 2023. Retrieved 28 April 2023.
  2. ^ "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.
  3. ^ "Camzyos (Bristol-Myers Squibb Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 7 October 2022. Archived from the original on 13 November 2022. Retrieved 28 April 2023.
  4. ^ Anvisa (31 March 2023). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 4 April 2023). Archived from the original on 3 August 2023. Retrieved 16 August 2023.
  5. ^ "Camzyos Product information". Health Canada. Archived from the original on 3 January 2023. Retrieved 2 January 2023.
  6. ^ "Summary Basis of Decision for Camzyos". Health Canada. 12 April 2023. Archived from the original on 3 August 2023. Retrieved 5 June 2023.
  7. ^ "Details for: Camzyos". Health Canada. 9 January 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  8. ^ a b c d e f g "Camzyos- mavacamten capsule, gelatin coated". DailyMed. 28 April 2022. Archived from the original on 3 July 2022. Retrieved 15 May 2022.
  9. ^ a b c "Camzyos EPAR". European Medicines Agency (EMA). 24 July 2023. Archived from the original on 3 August 2023. Retrieved 2 August 2023.
  10. ^ Edelberg JM, Sehnert AJ, Mealiffe ME, Del Rio CL, McDowell R (September 2022). "The Impact of Mavacamten on the Pathophysiology of Hypertrophic Cardiomyopathy: A Narrative Review". American Journal of Cardiovascular Drugs. 22 (5): 497–510. doi:10.1007/s40256-022-00532-x. PMC 9467968. PMID 35435607.
  11. ^ "Bristol Myers Squibb Completes Acquisition of MyoKardia, Strengthening Company's Leading Cardiovascular Franchise" (Press release). Bristol Myers Squibb. 17 November 2020. Archived from the original on 29 April 2022. Retrieved 29 April 2022 – via Business Wire.
  12. ^ "FDA approves new drug to improve heart function in adults with rare heart condition" (Press release). U.S. Food and Drug Administration (FDA). 29 April 2022. Archived from the original on 29 November 2022. Retrieved 29 November 2022.
  13. ^ "FDA approves Bristol Myers' oral heart disease drug". Reuters. 29 April 2022. Archived from the original on 29 November 2022. Retrieved 29 November 2022.
  14. ^ "U.S. Food and Drug Administration Approves Camzyos (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms" (Press release). Bristol Myers Squibb. 28 April 2022. Archived from the original on 29 April 2022. Retrieved 29 April 2022 – via Business Wire.
  15. ^ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Archived from the original on 21 January 2023. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  16. ^ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  17. ^ "Mavacamten Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 27 April 2016. Archived from the original on 3 July 2022. Retrieved 29 April 2022.
  18. ^ a b "Camzyos: Pending EC decision". European Medicines Agency (EMA). 26 April 2023. Archived from the original on 29 April 2023. Retrieved 27 April 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  19. ^ "Camzyos". Union Register of medicinal products. 27 June 2023. Archived from the original on 3 August 2023. Retrieved 2 August 2023.
  20. ^ Priyan, Vishnu (27 June 2023). "EC approves BMS' Camzyos for hypertrophic cardiomyopathy". Pharmaceutical Technology. Archived from the original on 27 June 2023. Retrieved 27 June 2023.
  21. ^ "FDA approves new drug to improve heart function in adults with rare heart condition". U.S. Food and Drug Administration (FDA). 29 April 2022. Archived from the original on 29 November 2022. Retrieved 29 November 2022.
  22. ^ "Health Canada Approves Camzyos (mavacamten capsules) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy". Bristol Myers Squibb (Press release). 10 November 2022. Archived from the original on 27 June 2023. Retrieved 27 June 2023.
  23. ^ "Camzyos". Therapeutic Goods Administration (TGA). 13 October 2022. Archived from the original on 5 February 2023. Retrieved 28 June 2023.
  24. ^ "의약품안전나라". Ministry of Food and Drug Safety (in Korean). Archived from the original on 2 July 2023. Retrieved 27 June 2023.
  25. ^ "LianBio Announces Marketing Approval of Camzyos (mavacamten) in Singapore". BioSpace. Archived from the original on 27 June 2023. Retrieved 27 June 2023.
  26. ^ "Camzyos, Hartkapseln (Mavacamtenum)". Swissmedic. Archived from the original on 27 June 2023. Retrieved 27 June 2023.
  27. ^ "Camzyos (mavacanteno): novo registro". Agência Nacional de Vigilância Sanitária - Anvisa (in Brazilian Portuguese). Archived from the original on 27 June 2023. Retrieved 27 June 2023.
  28. ^ "LianBio Announces Marketing Approval of Camzyos (mavacamten) in the Macau Special Administrative Region (SAR) of China" (Press release). LianBio. 11 May 2023. Archived from the original on 28 June 2023. Retrieved 28 June 2023 – via GlobeNewswire.
  29. ^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 78". WHO Drug Information. 31 (3). hdl:10665/330961.

Further reading

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  • Clinical trial number NCT03470545 for "Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy (EXPLORER-HCM)" at ClinicalTrials.gov
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