FDA Approves New Heart Failure Drug
The U.S. Food and Drug Administration (FDA) on July 7 approved Novartis’ Entresto (sacubitril/valsartan) to treat chronic heart failure. The drug is usually taken with other heart failure treatments and replaces angiotensin-converting enzyme inhibitors and other angiotension receptor blockers.
In the PARADIGM-HF study, Entresto was shown to reduce the risk of cardiovascular death and heart failure hospitalization as compared to the angiotensin-converting enzyme inhibitor enalapril. Side effects of the drug include hypotension, hyperkalemia and renal impairment.
“The FDA’s approval of Entresto (sacubitril/valsartan), a first-in-class combined angiotensin receptor neprilysin inhibitor, is a major advance in systolic heart failure care,” said Sean Pinney, MD, FACC, editorial team lead of the ACC.org Heart Failure and Cardiomyopathies Clinical Topic Collection, and director of the Advanced Heart Failure & Cardiac Transplant Program at Mount Sinai Medical Center in New York, NY. “The approval was supported by the successful outcome of the PARADIGM-HF trial, which showed meaningful reductions in heart failure hospitalization, cardiovascular death and all-cause mortality compared to the angiotensin converting enzyme inhibitor enalapril. The use of a run-in phase and underrepresentation of certain populations has led to appropriate concerns about hypotension and angioedema, especially in African Americans. Lingering questions about pricing and its appropriate positioning in the clinical guidelines will be addressed in the months ahead.”
Read the FDA’s announcement.
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