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.
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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.
As well as highlighting Novartis's burgeoning pipeline, the Swiss major's CEO is confident that its biggest earners will continue to growth for the next five years at least.
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