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FDA approval for new heart failure medicine to reduce risk of CV death and HF hospitalization

News - July 22, 2015

The US Food and Drug Administration (FDA) has approved sacubitril/valsartan tablets, previously known as LCZ696, for the treatment of heart failure (HF) with reduced ejection fraction (HFrEF). Sacubitril/valsartan tabletswill be available on prescription for patients whose condition is classified NYHA class II-IV, indicated to reduce the risk of cardiovascular death and HF hospitalization. It is a first in class medicine (an ARNI, Angiotensin Receptor Neprilysin Inhibitor) that reduces the strain on the failing heart. A twice-a-day tablet, it acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).It is usually administered in conjunction with other HF therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.

The FDA's decision is based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown sacubitril/valsartan tablets significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study, patients with HFrEF who were given the ARNI 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 sacubitril/valsartan had a similar tolerability profile to enalapril.

"The very meaningful survival advantage of sacubitril/valsartan seen in the PARADIGM-HF trial should persuade physicians to consider sacubitril/valsartan 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. "Sacubitril/valsartan is expected to change the management of patients with HFrEF for years to come."

Results from the 8,442 patient PARADIGM-HF study showed, versus enalapril, that the ARNI:
- reduced the risk of death from cardiovascular causes by 20%
- reduced heart failure hospitalizations by 21%
- reduced the risk of all-cause mortality by 16%
Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or time to first heart failure hospitalization.

Fewer patients on sacubitril/valsartan discontinued study medication for any adverse event compared to those on enalapril. The ARNI group had more hypotension and non-serious angioedema but less renal impairment, hyperkalemia and cough than the enalapril group.

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.
Sacubitril/valsartanis currently undergoing review by Health Authorities around the world, including in Canada, Switzerland and the EU.
 Press release Novartis July 7 2015

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