Camzyos FDA Approval History
Last updated by Judith Stewart, BPharm on April 22, 2025.
FDA Approved: Yes (First approved April 28, 2022)
Brand name: Camzyos
Generic name: mavacamten
Dosage form: Capsules
Company: Bristol-Myers Squibb Company
Treatment for: Hypertrophic Cardiomyopathy
Camzyos (mavacamten) is a first-in-class cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
- Hypertrophic cardiomyopathy is a type of heart disease characterized by thickening of the heart muscle and stiffness in the left ventricle. Obstruction occurs when the thickened septum causes a narrowing that can block or reduce blood flow from the left ventricle to the aorta, making it harder for the heart to expand normally and fill with blood.
- Camzyos is an allosteric and reversible inhibitor selective for cardiac myosin. It is thought to work by reducing cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance.
- Camzyos capsules are administered orally once daily.
- Warnings and precautions associated with Camzyos include heart failure, drug Interactions leading to heart failure or loss of effectiveness, and embryo-fetal toxicity.
- Common adverse reactions include dizziness and syncope.
Development timeline for Camzyos
Further information
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