Bristol Myers Squibb said the FDA has accepted a supplemental New Drug Application for Camzyos (mavacamten) as a potential treatment for adolescents aged 12 to under 18 years with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). If approved, Camzyos would become the first cardiac myosin inhibitor available for adolescents with oHCM and has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) date of September 30, 2026. Camzyos is already approved in adults with symptomatic New York Heart Association class II–III oHCM to improve functional capacity and symptoms and has been prescribed by more than 4,500 healthcare providers to nearly 25,000 patients in the United States.
Cristian Massacesi, MD, executive vice president, chief medical officer and head of development at Bristol Myers Squibb, said the filing offers an opportunity to extend the company’s oHCM treatment approach to a younger patient group.
The sNDA is supported by data from the Phase 3 SCOUT-HCM trial, which met its primary endpoint by demonstrating a clinically meaningful and statistically significant reduction from baseline in Valsalva left ventricular outflow tract gradient at Week 28 with Camzyos compared with placebo. The safety profile in symptomatic adolescents with oHCM was similar to that seen in adults, and no patients experienced a left ventricular ejection fraction below 50%. Results from the 28‑week period of SCOUT-HCM were presented at the 2026 American College of Cardiology Annual Scientific Session & Expo and published simultaneously in The New England Journal of Medicine.
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