Novartis Entresto granted expanded indication in chronic heart failure by FDA

• Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)^1-3 
  
  
• Expanded indication enables potential treatment of more adults with left ventricular ejection fraction (LVEF) below normal, the group where benefits are most clearly evident¹ 
  
  
• Of the more than 6 million Americans suffering from chronic heart failure (CHF), approximately 5 million may be appropriate for treatment with Entresto^3,4

Basel, February 16, 2021 — Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure¹. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal¹. The label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat¹.

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)^1-3.

“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^2,5,6. The greatest benefit was shown in patients with LVEF below normal⁶.

Approximately 6 million Americans are living with chronic heart failure (CHF)⁴. Approximately 3 million have HFrEF, and of the remaining 3 million, about 2 million have HFpEF with LVEF below normal^2-4. The prevalence of heart failure (HF) is increasing as the population ages⁴. Patients often face worsening symptoms that result in frequent HF hospitalizations⁷. Each hospitalization event is associated with worsening long-term prognosis⁷. Approximately one in four patients are re-admitted for HF and 10 percent may die within 30 days of discharge^8,9. Overall CHF death rates remain significantly high, with up to half of patients dying within five years of a HF diagnosis⁴.