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Novartis’ Entresto Labeling Expansion Bid Heads To US FDA Panel

 
• By Sue Sutter

Cardiovascular and Renal Drugs Advisory Committee will consider whether exploratory analyses from the PARAGON-HF trial, which narrowly missed its primary endpoint, plus demonstrated efficacy in an adjacent indication, support a new claim for heart failure patients with preserved ejection fraction.

Small narrow living room with space problems and a sofa between walls (3D Rendering)
The Entresto trial in heart failure patients with preserved ejection fraction narrowly missed its primary endpoint. • Source: Shutterstock

The US Food and Drug Administration is asking its external experts whether Novartis AG’s Entresto (sacubitril/valsartan) should add an indication for use in heart failure patients with preserved ejection fraction (HFpEF) despite narrowly missing the primary efficacy endpoint in the pivotal trial.

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