FDA Expands Mavacamten Approval for Pediatric Obstructive Hypertrophic Cardiomyopathy

The U.S. Food and Drug Administration (FDA) has expanded the approval of mavacamten (Camzyos) to include pediatric patients weighing at least 66 pounds (30 kg) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This makes mavacamten the only FDA-approved therapy for oHCM in a pediatric population, based on findings from the Phase 3 SCOUT-HCM trial which showed a significant reduction in Valsalva left ventricular outflow tract (LVOT) gradient.