Novartis’ heart failure med Entresto scores an expanded approval in the US

Pharmaceutical News

Novartis’ Entresto has been approved by the US Food and Drug Administration (FDA) for an expanded indication in chronic heart failure.

The new FDA approval has indicated Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalisation for heart failure in adult patients with chronic heart failure.

The new indication approval is based on evidence from Novartis’ PARAGON-HF trial – a Phase III study in patients with guide-line defined heart failure with preserved ejection fraction (HFpEF).

According to Novartis, the greatest benefit from Entresto treatment was shown in patients with left ventricular ejection fraction (LVEF) below normal.

“This approval is a significant advancement, providing a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region we normally considered reduced,”  said Scott Solomon, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, and PARAGON-HF executive committee co-chair.

“Until now, treatment for these patients was largely empiric. We can now offer a treatment to a wider range of patients who have an LVEF below normal,” he added.

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