Swiss pharmaceutical company Novartis has secured the expanded US Food and Drug Administration (FDA) indication for Entresto, a Novartis therapy to treat patients diagnosed with guideline-defined heart failure.
This therapy helps to reduce the risk of cardiovascular death as well as hospitalisation for heart failure in adult patients with chronic heart failure.
The expanded FDA label allows potential treatment of more adults with the left ventricular ejection fraction (LVEF) below normal.
Novartis noted that Entresto is a treatment beneficial for patients who are diagnosed with guideline-defined heart failure, which includes both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF).
The FDA endorsed Entresto is based on efficacy and safety evidence observed in PARAGON-HF, the Phase III active-controlled study to date in patients with guideline-defined HFpEF.
PARAGON-HF executive committee co-chair, Harvard Medical School and Brigham and Women’s Hospital Medicine professor, managing director Scott Solomon said: “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.
“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.”
According to Novartis, nearly six million Americans are suffering with chronic heart failure (CHF) and about three million have HFrEF, of which about two million have HFpEF with LVEF below normal.
Novartis Pharmaceuticals president Marie-France Tschudin said: “We are proud of our goal to reimagine medicine. This commitment has enabled us to bring Entresto to millions more heart failure patients in the US, many of whom did not have an approved treatment option until now.”