- Source: Mavacamten
Mavacamten, sold under the brand name Camzyos, is a medication used to treat obstructive hypertrophic cardiomyopathy.
Mavacamten is a small-molecule allosteric and cardiac myosin inhibitor. It was developed by MyoKardia, a subsidiary of Bristol Myers Squibb. 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.
Mavacamten was approved for medical use in the United States in April 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.
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.
Adverse effects
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.
History
Mavacamten was granted orphan drug designation by the US Food and Drug Administration (FDA).
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). The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG. In June 2023, the European Commission approved Mavacamten.
Mavacamten is approved for use in the US, Canada, Australia, South Korea, Singapore, Switzerland, Brazil and Macau.
= Names
=Mavacamten is the international nonproprietary name (INN).
References
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
Kata Kunci Pencarian:
- Mavacamten
- Hypertrophic cardiomyopathy
- Brazilian Controlled Drugs and Substances Act
- ATC code C01
- Cytokinetics
- Bristol Myers Squibb
- List of drugs granted breakthrough therapy designation
- CYP2C19