- LCZ696 is the first and only treatment to show a significant mortality benefit in a head-to-head trial against ACE-inhibitor enalapril1
- Heart failure is a life-threatening condition affecting nearly 5 million Indians 2
- LCZ696 brings hope of longer life and fewer hospitalisations for millions of patients with heart failure with reduced ejection fraction
Mumbai, July 10, 2015 – Novartis announced yesterday that the US Food and Drug Administration (FDA) has approved LCZ696 (sacubitril/valsartan) tablets, for the treatment of heart failure with reduced ejection fraction. LCZ696 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
“Early approval by the US FDA, ahead of its priority review date, has truly excited us as LCZ696 will benefit the many patients afflicted with heart failure with reduced ejection fraction. Novartis India is working hard to bring this important treatment to Indian patients in a timely way,” said Ranjit Shahani, Country President, Novartis India. “LCZ696 reduces risk of death from cardiovascular causes by 20% and will offer these patients a much greater opportunity to live longer and stay out of hospital. LCZ696 is expected to change the management of heart failure in the years to come.”
The US FDA’s decision was based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown LCZ696 significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. 1 At the end of the study, patients with reduced ejection fraction who were given LCZ696 were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that LCZ696 had a similar tolerability profile to enalapril. The PARADIGM – HF study demonstrated reduced risk of death from cardiovascular causes by 20%, reduced heart failure hospitalisations by 21% and reduced the risk of all-cause mortality by 16%.3 India had 637 patients in this study.
“The approval of LCZ696, even though in the US for now, is great news for the thousands of patients with congestive heart failure. Similar to the rest of the world, repeated hospitalisations for heart failure is common in India too,” said Dr. Jamshed Dalal, Director Cardiac Sciences, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Mumbai. “The novel drug LCZ696, based on the wonderful scientific concept of modulating neuro hormonal imbalance that reduces symptoms and cardiac events and increases survival can be considered a breakthrough in the management of heart disease. A new chapter has opened in the management of heart failure bringing relief to countless patients.”
Heart failure is a debilitating, life-threatening condition in which the heart cannot pump enough blood around the body. Patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention significantly impact quality of life. 4 LCZ696 is currently undergoing review by Health Authorities around the world. CCI Newswire