Novartis’ Entresto Labeling Expansion Bid Heads To US FDA Panel
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.
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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.
Keeping Track: Submissions From Sanofi, Merck, Novartis; Breakthrough Designations For GSK And Takeda
The latest news of submissions and expedited review designations from the Pink Sheet’s US FDA Performance Tracker
PARAGON-HF: Novartis Hangs Onto Hope For Entresto In HFpEF
Despite Phase III miss, Novartis is hopeful that the totality of the evidence will secure it at least a limited label expansion to a sizable but harder to treat portion of the heart failure market than Entresto already serves.