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.

metronome with heart
FDA’s cardio-renal committee voted 12-1 in favor of a new heart failure claim for Entresto. • Source: Getty

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