Camzyos FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 24, 2022.
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
|Apr 30, 2022||Approval FDA Approves Camzyos (mavacamten) for the Treatment of Symptomatic NYHA Class II-III Obstructive Hypertrophic Cardiomyopathy|
|Apr 3, 2022||Bristol Myers Squibb Announces Data from EXPLORER-LTE Demonstrating Sustained Improvements in Clinically Meaningful Cardiovascular Outcomes at Weeks 48 and 84 in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy Receiving Mavacamten|
|Apr 2, 2022||Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial|
|Feb 16, 2022||Bristol Myers Squibb Announces Positive Topline Results from Phase 3 VALOR-HCM Trial, Evaluating Mavacamten in Patients with Obstructive Hypertrophic Cardiomyopathy Who are Eligible for Septal Reduction Therapy|
|May 15, 2021||Bristol Myers Squibb Presents Late-Breaking Phase 3 Data Demonstrating Health Status Benefits of Mavacamten in Patients with Obstructive Hypertrophic Cardiomyopathy at American College of Cardiology’s 70th Annual Scientific Session|
|May 3, 2021||Bristol Myers Squibb Presents New Clinical and Real-World Data on Mavacamten and Obstructive Hypertrophic Cardiomyopathy at Upcoming American College of Cardiology’s 70th Annual Scientific Session|
|Mar 19, 2021||U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)|
|Aug 29, 2020||MyoKardia Presents Results from Phase 3 EXPLORER-HCM Clinical Trial of Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy|
|Jul 23, 2020||MyoKardia Announces Receipt of Breakthrough Therapy Designation from FDA for Mavacamten for the Treatment of Symptomatic, Obstructive Hypertrophic Cardiomyopathy|
|Nov 11, 2019||MyoKardia Announces 48-week Data from PIONEER-OLE Study of Mavacamten|
|Nov 11, 2019||MyoKardia Announces Positive Topline Data from its Phase 2 MAVERICK-HCM Clinical Trial of Mavacamten|
|Mar 8, 2018||MyoKardia Announces Positive Results from Low-Dose Cohort of Phase 2 PIONEER-HCM Study of Mavacamten in Symptomatic, Obstructive Hypertrophic Cardiomyopathy Patients|
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