Novartis’ Entresto narrowly misses Phase 3 goal in heart failure patients
New Phase 3 data for Novartis’ Entresto (sacubitril/valsartan) have been released, showing that the therapy narrowly missed its primary endpoint but still presented clinical benefit compared to valsartan in heart failure patients with preserved ejection fraction (HFpEF).
The findings of the study showed that Entresto reduced the total (first and recurrent) heart failure hospitalisations and cardiovascular (CV) death experienced by patients by 13%, falling just short of the primary endpoint. Still, the company said that these data “may result in clinically important benefits” in particular HFpEF subgroups; specifically, patients with a left ventricular ejection fraction equal to or below the median of 57% saw a higher reduction of 22%, while female participants saw a reduction of 27.5%.
“While the reduction in the primary endpoint was not statistically significant, the totality of evidence from PARAGON-HF suggests potential overall benefit of sacubitril/valsartan compared with valsartan in HFpEF, particularly in patients with ejection fraction below normal,” remarked Dr Scott Solomon, Director of Noninvasive Cardiology at Brigham and Women’s Hospital, Professor, Harvard Medical School, and Executive Committee Co-Chair on Novartis’ PARAGON-HF trial. “It also highlights the complexity of HFpEF and may suggest that some treatments have a more pronounced impact in certain patient groups, including women, who are more likely to suffer from this condition than men.”
Dr John McMurray, Professor of Medical Cardiology at University of Glasgow and PARAGON-HF Executive Committee Co-Chair, remarked: “PARAGON-HF provides a wealth of data that will advance our understanding of HFpEF and the patients it affects. When considered in the context of the PARADIGM-HF trial, it is not surprising that sacubitril/valsartan might have a greater treatment effect in HFpEF patients with an ejection fraction in the lower part of the range we studied in PARAGON-HF.”
Novartis confirmed it will pursue conversation with regulatory authorities on the next steps in securing regional approval of the therapy.
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