Bristol Myers Squibb announces US FDA approves addition of positive data from phase 3 VALOR-HCM study to Camzyos label
Bristol Myers Squibb announced that the US 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 US 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
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