Novartis’ Entresto falls short at Phase 3 in heart failure with preserved ejection fraction

pharmafile | July 29, 2019 | News story | Research and Development, Sales and Marketing Entresto, Novartis, heart failure, pharma 

Novartis has been rocked by new Phase 3 data from a global trial into the efficacy of Entresto (sacubitril/valsartan), revealing that the therapy failed to meet its composite primary endpoint in the treatment of patients who have suffered heart failure with preserved ejection fraction (HFpEF).

The company confirmed that the therapy “narrowly missed statistical significance” in the reduction of cardiovascular death and total heart failure hospitalisations compared to active comparator valsartan in 4,822 participants – the largest study into HFpEF to date.  

HFpEF refers to a specific kind of heart failure characterised by the failure of the heart’s ventricles to relax as normal during ventricular filling, despite normal muscle contraction. The event is associated with high rates of hospitalisation, as well as increased mortality and poor quality of life. At the moment, there is no approved treatment for the condition.

Despite the disappointment, Novartis said it would be ready to discuss the findings with clinical experts and regulators to determine the next steps to develop the therapy: “The totality of evidence from the trial suggests that treatment with sacubitril/valsartan may result in clinically important benefits in HFpEF,” explained Dr John Tsai, Global Drug Development and Chief Medical Officer, Novartis, “We thank the patients, investigators and site personnel around the world for their support during the PARAGON-HF study. We will be discussing potential next steps with clinical experts and regulators while we prepare to present the full results at the ESC Congress 2019 in September.”

Matt Fellows

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