FDA Update: Mavacamten Approved For Obstructive HCM

The U.S. Food and Drug Administration (FDA) has approved mavacamten (2.5 mg, 5 mg, 10 mg, 15 mg capsules) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (HCM). According to Bristol Myers Squibb (BMS), the drug "is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM."

The approval comes on the heels of the EXPLORER-HCM long-term extension study, which was presented during ACC.22, and showed that use of mavacamten to treat symptomatic obstructive HCM resulted in continued benefits in patient quality of life and outcomes over an extended period of time. Specifically, researchers said mavacamten was associated with significant and sustained improvements in left ventricular outflow tract gradients.

Mavacamten will be available through the restricted Risk Evaluation and Mitigation Strategy program and includes a boxed warning about the potential risk for heart failure. Read the BMS notice for more detailed information about heart failure risk, as well as contraindications, drug interactions, adverse reactions and treatment of special populations, including pregnant patients.

Clinical Topics: Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ACC Advocacy, Quality of Life, Drug Labeling, Risk Evaluation and Mitigation, United States Food and Drug Administration, Cardiomyopathy, Hypertrophic, Heart Failure, Contraindications, Drug Interactions, Cardiac Myosins

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