Novartis' 'breakthrough' therapy Entresto has received a strong endorsement in updated global guidelines on the treatment of heart failure.
Cardiac experts in both the European Union and US have given the top-level "class 1" recommendation to the drug, highlighting its benefits for patients in significantly reducing the risk of death due to cardiovascular causes or related hospitalisation.
Heart failure is a debilitating and life-threatening condition, affecting over 60 million people worldwide. Around half of patients have reduced ejection fraction (HFrEF), where the heart does not contract with enough force, so less blood is pumped out.
Entresto (sacubitril/valsartan, formerly LCZ696) offers a novel dual mechanism of action thought to reduce the strain on the failing heart: valsartan suppresses the harmful effects of angiotensin II on the cardiovascular system, while sacubitril blocks the enzyme neprilysin to enhance the protective neurohormonal systems of the heart.
The fanfare surrounding its launch stems from the fact that it is the first treatment shown to offer a significant mortality benefit over an ACE-inhibitor; with data from the 8,442 patient PARADIGM-HF demonstrating that it cut cardiovascular deaths by 20% versus enalapril, as well as heart failure hospitalisations and all-cause mortality by 21% and 16%, respectively.
In the EU, the European Society of Cardiology now recommends that doctors switch appropriate HFrEF patients to Entresto from an ACE or ARB, while US guidelines - by the American College of Cardiology, the American Heart Association and the Heart Failure Society of America - also endorse Novartis' drug as standard of care as an alternative to ACEs or ARBs, and also call for doctors to switch over patients with mild to moderate symptoms.
"These strong, swift and broad recommendations by US cardiology organisations, redefine the standard of care for how reduced ejection fraction heart failure is treated," said Vas Narasimhan, Global Head of Development and Chief Medical Officer for Novartis. "We know patients with heart failure suffer reduced quality of life and remain at high risk of hospitalisation or death, and these new guidelines are a strong call to action to ensure patients receive the most effective therapies."