The US Food and Drug Administration announced the approval of Entresto for the treatment of heart failure.
The US Food and Drug Administration announced the approval of Entresto (sacubitril/valsartan) for the treatment of heart failure.
According to a release from the FDA, the medication has been shown to “reduce the rate of cardiovascular death and hospitalization related to heart failure.”
With more than 5.1 million people affected by heart failure in the US, Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research said, “Heart failure is the leading cause of death and disability in adults.” He added, ‘Treatment can help people with heart failure live longer and enjoy more active lives.”
The FDA release noted that Entresto, manufactured by Novartis, was approved under the agency’s “priority review program” and was also granted fast track designation. During its development the medication was tested in a study involving more than 8000 patients “and was shown to reduce the rate of cardiovascular death and hospitalizations related to heart failure compared to another drug enalapril.”
Side effects reported include low blood pressure, high potassium levels, and renal impairment. Some patients also reported angioedema, especially black patients and those with a prior history of the condition.