Novartis’ Entresto Gains US FDA Panel Nod For New Heart Failure Claim
But advisory committee members debate how to define the target population for a new indication, shying away from use of ‘preserved’ to characterize heart failure patients with ejection fraction levels below normal but greater than the definition of ‘reduced’ EF.
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The SGLT2 inhibitor has better efficacy and clearer labeling than Novartis’s Entresto in heart failure with preserved ejection fraction, but AstraZeneca’s Farxiga is expected to produce Phase III data by June.
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.
CEO Vas Narasimhan sees Novartis very much as an innovative company so the long-awaited strategic review of Sandoz suggests that the generics/biosimilars business could be spun off or sold fairly soon.