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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)

BMY
  • Bristol Myers Squibb announced that the U.S. FDA accepted a supplemental New Drug Application (sNDA) for Camzyos (mavacamten) as a potential treatment for adolescents (ages 12 to <18 years) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
  • If approved, Camzyos would be the first cardiac myosin inhibitor (CMI) indicated for treating oHCM in adolescents, addressing a high unmet medical need for this population.
  • The FDA granted the application Priority Review status with a Prescription Drug User Fee Act (PDUFA) date of September 30, 2026.
  • The sNDA submission was based on positive results from the Phase 3 SCOUT-HCM trial, which met its primary endpoint by demonstrating a clinically meaningful \& statistically significant reduction in Valsalva left ventricular outflow tract (LVOT) gradient at Week 28 versus placebo.
  • The safety profile of Camzyos in adolescents was similar to that observed in adults, with no patients experiencing a left ventricular ejection fraction (LVEF) below 50% during the trial.
  • SCOUT-HCM enrolled 44 adolescent patients in a randomized, double-blind, placebo-controlled international trial including a 28-week placebo-controlled period, a 28-week active-treatment crossover period, \& an open-label long-term extension.
  • Camzyos is currently approved for adults with NYHA class II-III oHCM \& has been prescribed by over 4,500 healthcare providers to nearly 25,000 patients in the U.S.
  • CAMZYOS carries a Boxed WARNING for the risk of heart failure due to systolic dysfunction, requiring LVEF monitoring prior to \& during treatment.
  • CAMZYOS is contraindicated for concomitant use with strong CYP2C19 inhibitors or moderate to strong CYP2C19/CYP3A4 inducers due to the risk of heart failure or loss of efficacy.
  • The drug is available only through a restricted REMS program requiring certification for prescribers, pharmacies, \& patients to monitor LVEF \& mitigate heart failure risks.
  • Embryo-fetal toxicity risks are noted, requiring pregnancy testing \& effective contraception for females of reproductive potential during treatment \& for 4 months after the last dose.
  • Clinical trial results from the 28-week SCOUT-HCM period were presented at the American College of Cardiology (ACC) Annual Scientific Session \& Expo 2026 with simultaneous publication in The New England Journal of Medicine.