Novartis Entresto gets expanded indication in chronic heart failure by FDA

Novartis has received approval from the US Food and Drug Administration (FDA) after expanded indication for Entresto to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.

Novartis points out that benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. The label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat, Novartis said.

For the first time, there is a treatment with benefit for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF), Novartis 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,” said Scott Solomon, MD, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and PARAGON-HF Executive Committee Co-Chair.

“We can now offer a treatment to a wider range of patients who have an LVEF below normal.”

This label expansion is based on efficacy and safety evidence observed in PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with guideline-defined HFpEF. The greatest benefit was shown in patients with LVEF below normal, Novartis 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,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “This achievement would not have been possible without tremendous dedication from investigators, patients in our clinical trials and the advocacy community, to whom we are extremely grateful.”