FDA Approves Novartis’ Heart Failure Drug Entresto

The FDA Tuesday approved Novartis’ heart failure drug Entresto, which had received priority review and fast track designations to expedite therapies for life-threatening conditions and unmet medical needs.

A clinical trial involving more than 8,000 adults showed Entresto (sacubitril/valsartan) reduced the rate of cardiovascular deaths and hospitalizations related to heart failure compared with the angiotensin-converting enzyme inhibitor enalapril. Most patients in the study were also receiving beta-blockers, diuretics and mineralocorticoid antagonists.

Entresto should not be used with ACE inhibitors due to an increased risk of allergic reaction. — John Bechtel