Camzyos has the potential to be the first pharmacological therapy for the treatment of oHCM in adolescents, addressing a high unmet need for this population

Application based on positive results of Phase 3 SCOUT-HCM trial, which met its primary endpoint with safety profile similar to established profile in adults

Bristol Myers Squibb (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Camzyos (mavacamten) as a potential treatment for adolescents (ages 12 years to <18 years) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). If approved, Camzyos would be the first cardiac myosin inhibitor (CMI) to treat adolescents with oHCM. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) date of September 30, 2026. Camzyos is currently approved for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III oHCM to improve functional capacity and symptoms and has been prescribed by more than 4,500 healthcare providers (HCPs) to almost 25,000 patients in the U.S. alone.