A new drug that many hope could revolutionise treatment of a certain form of heart failure has now been given a green light for use in Europe.
Novartis’ Entresto (sacubitril/valsartan) has been approved by the European Commission to treat patients with heart failure and reduced ejection fraction, a condition where the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body.
Novartis’ eagerly awaited therapy - which has already been cleared for use in the US and is available in the UK through its Early Access to Medicines Scheme - offers a novel mechanism of action which is thought to reduce the strain on the failing heart.
The drug works in two ways - valsartan blocks the angiotensin II type-1 receptor, suppressing the harmful effects of angiotensin II on the cardiovascular system, while sacubitril blocks an enzyme known as neprilysin to enhance the protective neurohormonal systems of the heart.
Entresto is the first treatment shown to have 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.
Heart failure affects around 550,000 patients in the UK, around half of which will have reduced ejection fraction. Patients with heart failure have a poor prognosis despite available therapies, with only half alive five years after diagnosis, and the condition costs the NHS around £2.3 billion a year.
“There is a real need for new and effective treatments that reduce mortality and morbidity while improving patients’ quality of life,” noted Dimitrios Georgiopoulos, chief scientific officer at Novartis Pharmaceuticals UK, and said Entresto is a first-in-class treatment option that has demonstrated” a significant mortality benefit, including reducing the risk of sudden death versus, the current standard of care”, in patient with reduced ejection fraction.