European patients with a certain type of heart failure are on the verge of getting access to a novel treatment for their condition, after regulatory advisors backed approval of Novartis’ Entresto.
Entresto (sacubitril/valsartan) is being developed as a treatment for 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.
Every day 10,000 Europeans are diagnosed with heart failure and 15 million already live with the condition, 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, highlighting the huge room for improvement in outcomes.
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 that many believe could revolutionise treatment.
Entresto 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.
The drug 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.
Novartis is hoping for a European green light by the end of the year.