CAMZYOS (mavacamten)
Symptomatic obstructive hypertrophic cardiomyopathy · Adults and pediatric patients weighing 30 kg or more with symptomatic obstructive hypertrophic cardiomyopathy
BMY · BMYBristol-Myers Squibb Company
Regulatory designations
Full timeline
5 milestonesFDA approved the CAMZYOS pediatric label expansion
FDA approved an expanded CAMZYOS indication for symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms in adults and pediatric patients weighing 30 kg or more. The expansion makes CAMZYOS the first FDA-approved cardiac myosin inhibitor for a pediatric oHCM population.
Bristol Myers Squibb — FDA approval of expanded CAMZYOS indication↗FDA accepted the sNDA with Priority Review
FDA accepted the application based on the Phase 3 SCOUT-HCM trial and granted Priority Review.
Bristol Myers Squibb — sNDA acceptance and Priority Review↗Detailed SCOUT-HCM results were presented and published
CAMZYOS produced a clinically meaningful and statistically significant reduction in Valsalva left-ventricular outflow-tract gradient, with no new safety signals in the 44-patient trial.
Bristol Myers Squibb — Detailed Phase 3 SCOUT-HCM results↗SCOUT-HCM reported positive topline results
The Phase 3 trial met its primary endpoint and multiple secondary endpoints, and the safety findings were consistent with the established adult profile.
Bristol Myers Squibb — Positive SCOUT-HCM topline results↗Related News
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