Cardiology Could Get A Jolt As FDA Reviews Novel Heart Failure Candidates From BMS, Cytokinetics

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.

Cardiovascular
• Source: Alamy

Cardiology has been a quiet area for new drug approvals over the past decade, but the field is heading into what could be a productive period. Candidates are under review both for heart failure patients with reduced ejection fraction and those with preserved ejection fraction, while a race is developing in obstructive hypertrophic cardiomyopathy treatment between two candidates with a common forebearer.

Notably, two of the pending applications hold a breakthrough therapy designation (BTD): Bristol Myers Squibb Company’s mavacamten for obstructive hypertrophic cardiomyopathy (oCHM) and a new indication for Boehringer...

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