Mavacamten
Mavacamten, sold under the brand name Camzyos, is a medication used to treat obstructive hypertrophic cardiomyopathy.[4]
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Trade names | Camzyos |
Other names | MYK-461 |
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Routes of administration | By mouth |
Drug class | Cardiac myosin inhibitor |
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Formula | C15H19N3O2 |
Molar mass | 273.336 g·mol−1 |
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Mavacamten is a cardiac myosin inhibitor.[4] It was developed by MyoKardia, a subsidiary of Bristol Myers Squibb.[5]
Mavacamten was approved for medical use in the United States in April 2022.[4][6][7][8] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]
Medical uses
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.[4]
History
Mavacamten was granted orphan drug designation by the U.S. Food and Drug Administration (FDA).[10]
Society and culture
Legal status
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).[11] The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[11]
Names
Mavacamten is the international nonproprietary name (INN).[12]
References
- "Camzyos". Therapeutic Goods Administration (TGA). 13 October 2022. Archived from the original on 5 February 2023. Retrieved 28 April 2023.
- "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.
- "Camzyos Product information". Health Canada. Archived from the original on 3 January 2023. Retrieved 2 January 2023.
- "Camzyos- mavacamten capsule, gelatin coated". DailyMed. 28 April 2022. Archived from the original on 3 July 2022. Retrieved 15 May 2022.
- "Bristol Myers Squibb Completes Acquisition of MyoKardia, Strengthening Company's Leading Cardiovascular Franchise". Business Wire. 17 November 2020. Archived from the original on 29 April 2022. Retrieved 29 April 2022.
- "FDA approves new drug to improve heart function in adults with rare heart condition" (Press release). U.S. Food and Drug Administration. 29 April 2022. Archived from the original on 29 November 2022. Retrieved 29 November 2022.
- "FDA approves Bristol Myers' oral heart disease drug". Reuters. 29 April 2022. Archived from the original on 29 November 2022. Retrieved 29 November 2022.
- "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.
- "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.
This article incorporates text from this source, which is in the public domain.
- "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.
- "Camzyos: Pending EC decision". European Medicines Agency. 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.
- 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
- Xie J, Wang Y, Xu Y, Fine JT, Lam J, Garrison LP (2022). "Assessing health-related quality-of-life in patients with symptomatic obstructive hypertrophic cardiomyopathy: EQ-5D-based utilities in the EXPLORER-HCM trial". Journal of Medical Economics. 25 (1): 51–58. doi:10.1080/13696998.2021.2011301. PMID 34907813.
External links
- Clinical trial number NCT03470545 for "Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy (EXPLORER-HCM)" at ClinicalTrials.gov