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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Boehringer Ingelheim’s cardiometabolism head Mohamed Eid considers the impact of EMPEROR-Preserved study on the heart failure treatment landscape and looks ahead at potential new conquests in kidney disease for its SGLT2 inhibitor.
The full dataset from the closely-watched study demonstrated that Jardiance showed a 21% reduction in the risk of cardiovascular death or hospitalization for HFpEF compared with placebo, a significantly greater benefit than seen with the only approved drug for the indication, Novartis's Entresto.
The company's pharma chief Marie-France Tschudin does not expect Entresto's "unique position" in heart failure to be threatened by SGLT2 inhibitors such as Jardiance and Farxiga, saying those drugs are add-ons that will be used predominantly in diabetes patients.