Novartis Entresto approval by the FDA

Novartis new heart failure medicine LCZ696, now called Novartis Entresto approved by the FDA to reduce risk of cardiovascular death and heart failure hospitalisation

  • First in the world approval brings hope of longer life and fewer hospitalizations for millions of Americans with heart failure with reduced ejection fraction
  • Entresto is the first and only treatment to show a significant mortality benefit in a head-to-head trial against ACE-inhibitor enalapril. See the PARADIGM HF trial
  • Heart failure is a life-threatening condition affecting nearly 6 million Americans; about half have the reduced ejection fraction form, HEFREF
  • Approval comes six weeks ahead of FDA’s priority review action date allowing Entresto to be available to US patients more quickly
  • Basel, July 7, 2015 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Entresto™ (sacubitril/valsartan) tablets, previously known as LCZ696, for the treatment of heart failure with reduced ejection fraction. Entresto will be available on prescription for patients whose condition is classified NYHA class II-IV, indicated to reduce the risk of cardiovascular death and heart failure hospitalisation. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.

“Despite the uncertainty and high financial risk we designed the world’s largest heart failure trial to compare Entresto to the previous gold standard. As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital,” said David Epstein, Division Head, Novartis Pharmaceuticals. “We recognize our responsibility to ensure Entresto reaches US patients and prescribers as soon as possible and will begin shipping in the US in the coming week.”

The FDA’s decision is based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study, patients with reduced ejection fraction who were given Entresto were more likely to be alive and less likely to have been hospitalised for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.

“The very meaningful survival advantage of Entresto seen in the PARADIGM-HF trial should persuade physicians to consider Entresto for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers,” said Dr. Milton Packer, Professor and Chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA. “Entresto is expected to change the management of patients with HFrEF for years to come.” 2/3

Entresto is currently undergoing review by Health Authorities around the world, including in Canada, Switzerland and the EU. Once approved by health authorities around the world, Entresto could achieve estimated peak sales in excess of $5 billion for the reduced ejection fraction indication.