FDA approves Novartis’ heart failure drug Entresto

pharmafile | February 17, 2021 | News story | Research and Development FDA, Novartis 

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

Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal, but the label states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat.

The approval makes Entresto the first 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).

Label expansion of the drug 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.

Around six million people in the US are living with chronic heart failure (CHF). Approximately three million have HFrEF, and about two million have HFpEF with LVEF below normal. The prevalence of heart failure (HF) is increasing as the population ages. Patients often face worsening symptoms that result in frequent HF hospitalisations, and each hospitalisation event is associated with worsening long-term prognosis.

Roughly one in four patients are re-admitted for HF, and 10% may die within 30 days of discharge. Overall CHF death rates remain significantly high, with up to half of patients dying within five years of a HF diagnosis.

Dr Scott Solomon, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and PARAGON-HF Executive Committee Co-Chair, 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.”

Marie-France Tschudin, President of Novartis Pharmaceuticals, commented: “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.

“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.”

Darcy Jimenez

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