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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, 2022Approval FDA Approves Camzyos (mavacamten) for the Treatment of Symptomatic NYHA Class II-III Obstructive Hypertrophic Cardiomyopathy
Apr  3, 2022Bristol 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, 2022Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial
Feb 16, 2022Bristol 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, 2021Bristol 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, 2021Bristol 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, 2021U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Aug 29, 2020MyoKardia Presents Results from Phase 3 EXPLORER-HCM Clinical Trial of Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Jul 23, 2020MyoKardia Announces Receipt of Breakthrough Therapy Designation from FDA for Mavacamten for the Treatment of Symptomatic, Obstructive Hypertrophic Cardiomyopathy
Nov 11, 2019MyoKardia Announces 48-week Data from PIONEER-OLE Study of Mavacamten
Nov 11, 2019MyoKardia Announces Positive Topline Data from its Phase 2 MAVERICK-HCM Clinical Trial of Mavacamten
Mar  8, 2018MyoKardia Announces Positive Results from Low-Dose Cohort of Phase 2 PIONEER-HCM Study of Mavacamten in Symptomatic, Obstructive Hypertrophic Cardiomyopathy Patients

Further information

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