FDA approves CAMZYOS for pediatric obstructive cardiomyopathy
The U.S. Food and Drug Administration has given approval to Bristol Myers Squibb's CAMZYOS (mavacamten) for treating pediatric patients with obstructive hypertrophic cardiomyopathy who weigh 30 kg or more. This expanded indication makes CAMZYOS the sole FDA-approved therapy for this pediatric population, as highlighted in the company's press release.
The FDA's approval stems from positive results from the Phase 3 SCOUT-HCM trial, which included 44 adolescent patients aged 12 to under 18 years. The trial compared CAMZYOS (23 patients) against a placebo group (21 patients) over a 28-week period. CAMZYOS proved successful in meeting the trial's primary endpoint, as it showed a statistically significant reduction in Valsalva left ventricular outflow tract gradient at Week 28 compared to the placebo group.
Specifically, the treatment group experienced a mean change of -49.4 mmHg, while the placebo group had a mean change of -1.8 mmHg. This resulted in a least-squares mean difference of -48.0 mmHg for CAMZYOS (p not specified).
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