Bristol-Myers Squibb's (BMY) Camzyos to treat symptomatic obstructive hypertrophic cardiomyopathy was approved by the US Food and Drug Administration for use in pediatric patients, the agency said in a statement Wednesday.
Camzyos, which was first approved for adults in 2022, is now approved for both adults and pediatric patients with weight of at least 30 kg with symptomatic oHCM, a genetically inherited condition that causes thickened heart muscle.
The company's phase 3 efficacy data revealed improved left ventricular outflow tract obstruction in participants suffering from the heart condition, according to the statement.
Camzyos received orphan drug designation for this indication, according to the agency.
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