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Novartis’ Entresto Gains US FDA Panel Nod For New Heart Failure Claim

 
• By Sue Sutter

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

A US Food and Drug Administration advisory committee overwhelmingly endorsed a new heart failure indication for Novartis AG’s Entresto (sacubitril/valsartan) but was more divided on how to define the target population for that new claim.

On 15 December, the Cardiovascular and Renal Drugs Advisory Committee voted 12-1 that the results of the PARAGON-HF study in heart failure patients with preserved ejection fraction (HFpEF), in

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