Entresto Approved for Heart Failure
July 7, 2015 – The U.S. Food and Drug Administration (FDA) approved Entresto (sacubitril/valsartan) indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduce ejection fraction. Entrecto is manufactured by Novartis and is an angiotensin receptor-nephrilysin inhibitor (ARNi). Heart failure affects about 5.1 million Americans and an estimated 2.2 million are considered NYHA Class II-IV with reduced ejection fraction who may be eligible for therapy with Enteresto, as demonstrated in a Paradigm – HF trial. In the trial Entresto therapy reduced the rate of cardiovascular death and hospitalizations related to heart failure compared to enalapril, which is an angiotensin converting enzyme (ACE) inhibitor.
Dosage forms for Entresto will include film coated tablets in three dosage strengths of including: 24/26mg, 49/51mg, and 97/103mg. Usually administered in combination with other heart failure therapies in place of ACE inhibitors or other angiotensin 2 receptor blockers (ARBs), the recommended starting dose for Entresto is 49/51mg, given twice daily, and to be increased after 2-4 weeks to the target maintenance dose of 97/103mg twice daily; as tolerated by the patient. Entresto was approved 6 months earlier than expected and it is anticipated to be a blockbuster drug with annual sales exceeding $5 billion.
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