FDA approves addition of positive data from phase III VALOR-HCM study to Camzyos label showing reduction of the composite endpoint of guideline-based eligibility for septal reduction therapy
Bristol Myers Squibb announced that the FDA approved the supplemental New Drug Application (sNDA) to add positive data from the Phase III VALOR-HCM study to the U.S. Prescribing Information for Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules)
Data added to the label showed that treatment with Camzyos significantly reduced the composite endpoint of guideline-based eligibility for septal reduction therapy (SRT) at Week 16 or the decision to proceed with SRT prior to or at Week 16. This approval follows last year’s FDA approval of Camzyos, based on results from the Phase III EXPLORER-HCM trial, for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms.
Catherine Owen, Senior Vice President and General Manager, U.S. Commercial, Bristol Myers Squibb said “Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the underlying source of the disease and is redefining the treatment landscape for symptomatic NYHA class II–III obstructive HCM. Results from the Phase III VALOR-HCM study reinforce the data from the Phase III EXPLORER-HCM trial and further strengthen the clinical profile of Camzyos.
The full U.S. Prescribing Information for Camzyos includes a Boxed WARNING for the risk of heart failure. Camzyos reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.
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