Entresto’s heart failure miss may not signal the end, given FDA’s openness to new endpoints

Despite narrowly missing its primary endpoint in the PARAGON-HF trial to treat heart failure patients with preserved ejection fraction, Entresto’s performance on secondary endpoints suggests the drug could still have a path forward in the population, which currently lacks any approved therapies.

Novartis AG (NYSE:NVS; SIX:NOVN) reported Sunday that 15% of patients receiving Entresto sacubitril/valsartan showed improved functionality vs. 12.6% of patients receiving valsartan alone, as measured by change from baseline at month eight on the New York Heart Association (NYHA) class (OR=1.45, 95% CI=1.13, 1.86). ...