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FDA Expands Mavacamten Label to Include Children With oHCM | AJMC

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FDA approves Camzyos for pediatric hypertrophic cardiomyopathy, first cardiac myosin inhibitor for children

The FDA has approved Bristol Myers Squibb's Camzyos (mavacamten) for treating symptomatic obstructive hypertrophic cardiomyopathy in pediatric patients, making it the first cardiac myosin inhibitor approved for children with this painful heart condition. The approval is based on positive results from the Phase 3 SCOUT-HCM trial.

Oct 1, 2026·5 sourcesFDA drug approvalClinical trials
FDA approves Camzyos for pediatric hypertrophic cardiomyopathy, first cardiac myosin inhibitor for children
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U.S. Food and Drug Administration Approves Expanded Indication for Bristol Myers Squibb’s CAMZYOS® (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) in Adults and Pediatric Patients*