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
