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2023 | HFSA

U.S. Food and Drug Administration Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to CAMZYOS® (mavacamten) Label

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PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (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® (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 3 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.

“At Bristol Myers Squibb, we are committed to delivering innovative medicines to help improve the lives of patients living with serious diseases,” said Catherine Owen, Senior Vice President and General Manager, U.S. Commercial, Bristol Myers Squibb. “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 3 VALOR-HCM study reinforce the data from the Phase 3 EXPLORER-HCM trial and further strengthen the clinical profile of CAMZYOS. We are proud to offer this important therapy to patients.”