FDA Approves Bristol Myers' Camzyos For Heart Disease

(RTTNews) - The U.S. Food and Drug Administration approved Bristol Myers Squibb's (BMY) Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.

The approval was based on phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo.

Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the source of obstructive hypertrophic cardiomyopathy.

Camzyos comes with a boxed warning for the risk of heart failure. The drug reduces left ventricular ejection fraction and can cause heart failure due to systolic dysfunction, the company said in a statement.