FDA expands indication for ARNI in chronic HFNews - Feb. 17, 2021
The US Food and Drug Administration (FDA) has approved an expanded indication for sacubitril/valsartan in adult patients with chronic heart failure (HF) to reduced the risk of CV death and hospitalization for heart failure. The label includes that benefits are most clearly evident in patients with LVEF below normal and that LVEF is a variable measure and clinical judgment should be used in deciding whom to treat.
Now, there is a treatment with for patients with heart failure including both HFrEF and many with HFpEF. “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” according to Scott Solomon, MD, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, Boston, MA, USA.
The expansion of the label is based on the findings from the PARAGON-HF trial in patients with HFpEF.