REMS For Mavacamten Could Involve Additional Monitoring, BMS Says
User Fee Delayed; Potential For Systolic Dysfunction Needs Watching
The FDA will take three more months to review mavacamten, a treatment for hypertrophic cardiomyopathy that BMS expects to be one of the company’s next blockbusters.
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Bristol already is training cardiologists at major treatment centers in how to treat obstructive hypertrophic cardiomyopathy with Camzyos (mavacamten) based on the REMS in the US label.
Upcoming US FDA decisions could bring breakthrough-designated approvals for BI/Lilly’s Jardiance in heart failure with preserved ejection fraction and BMS’ mavacamten in hypertrophic cardiomyopathy, while Cytokinetics bids to bring a new mechanism the busy heart failure with reduced ejection fraction space and earns a BTD in HCM.
The REDWOOD-HCM study showed early, sustained efficacy and no serious adverse events with a drug Cytokinetics designed to be superior to mavacamten, a drug it spun out via BMS-acquired MyoKardia.