FDA approves sNDA for Bristol-Myers’ phase 3 VALOR-HCM study of CAMZYOS

Bristol Myers Squibb announced that the FDA approved the supplemental New Drug Application, sNDA, to add positive data from the Phase 3 VALOR-HCM study to the U.S. Prescribing Information for CAMZYOS. 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 3 EXPLORER-HCM trial, for the treatment of adults with symptomatic New York Heart Association class II-III obstructive HCM to improve functional capacity and symptoms. The full U.S. Prescribing Information for CAMZYOS includes a Boxed WARNING for the risk of heart failure. CAMZYOS reduces left ventricular ejection fraction and can cause heart failure due to systolic dysfunction. Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF less than55% is not recommended. Interrupt CAMZYOS if LVEF is less than50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status. Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers. Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the CAMZYOS REMS PROGRAM.