Novartis' new heart failure medicine LCZ696, now called Entresto(TM), approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization

Novartis International AG / Novartis' new heart failure medicine LCZ696, now called Entresto(TM), approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• 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[1]
  
  
• Heart failure is a life-threatening condition affecting nearly 6 million Americans; about half have the reduced ejection fraction form[2]
  
  
• Approval comes six weeks ahead of FDA's priority review action date allowing Entresto to be available to US patients more quickly

The digital press release with multimedia content can be accessed here:

Basel, July 7, 2015 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Entresto(TM) (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 hospitalization. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.[1]

"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."