Bristol‑Myers Squibb reported that its Phase 3 SCOUT‑HCM trial of Camzyos (mavacamten) in adolescents with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) met its primary endpoint, showing a statistically significant reduction in left‑ventricular outflow tract gradient at week 28 versus placebo. The study enrolled 44 patients aged 12 to <18 and demonstrated a clinically meaningful decrease in gradient that aligns with the therapeutic effect seen in adults.
Secondary endpoints were also met, with patients showing marked improvements in exercise capacity and symptom scores. The 6‑minute walk test increased on average, and the proportion of patients reporting NYHA class I or II symptoms rose, confirming that the drug not only reduces hemodynamic burden but also translates into better functional status.
Safety data mirrored the adult experience. Adverse events were comparable in frequency and severity to the adult SCOUT‑HCM trial, and no new safety signals emerged in the adolescent cohort. This consistency supports the drug’s tolerability across age groups.
The topline results position Camzyos as the first cardiac‑myosin inhibitor for adolescents, potentially opening a new market segment that has been underserved by current therapies. With over 20,000 U.S. adults already on therapy, the adolescent indication could add a substantial revenue stream and strengthen BMY’s growth portfolio in cardiovascular therapeutics.
Management emphasized the significance of the findings: “The SCOUT‑HCM topline results highlight the potential for Camzyos to be the first cardiac myosin inhibitor for adolescent patients with oHCM. We look forward to the opportunity to transform clinical care in this population,” said Cristian Massacesi, MD, Executive Vice President, Chief Medical Officer and Head of Development. BMY plans to seek regulatory approval in the U.S. and Europe in the coming year, with a potential launch that could capture a sizable share of the pediatric cardiology market.
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