1. Pink Sheet
  2. >>Regulatory Trackers

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.

In briefing documents released ahead of a 15 December meeting of the Cardiovascular and Renal Drugs Advisory Committee, the agency suggested the overall results from the PARAGON-HF trial, including various prespecified and post hoc exploratory analysis, potentially could

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

More from Regulatory Trackers