U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos (mavacamten) to Treat Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

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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 PRINCETON, N.J., June 01, 2026--(BUSINESS WIRE)--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. "The acceptance of this NDA allows us the potential to extend our leadership in oHCM to a younger patient population with a high unmet medical need," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "We are encouraged by the possibility of bringing this potentially paradigm-shifting treatment to adolescents at a time when a condition like oHCM can significantly impact both physical and emotional aspects of their lives." The sNDA submission was based on data from the Phase 3 SCOUT-HCM trial, which met its primary endpoint, demonstrating a clinically meaningful and statistically significant reduction from baseline in Valsalva left ventricular outflow tract (LVOT) gradient at Week 28 with Camzyos versus placebo. The safety profile of Camzyos in symptomatic adolescents with oHCM was similar to that reported in adults, with no patients experiencing left ventricular ejection fraction (LVEF) of <50%. The results from the 28-week period of SCOUT-HCM were presented at the American College of Cardiology (ACC) Annual Scientific Session & Expo 2026, with simultaneous publication in The New Engl...

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