Novartis announced that the European Commission (EC) has approved EntrestoTM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart.
The approval is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study patients who were given Entresto 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 Entresto had a similar tolerability profile to enalapril.
Heart failure is a highly debilitating, life-threatening condition in which the heart cannot pump enough blood around the body because the muscles of the heart become too weak or too stiff to work properly. As a consequence patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact quality of life.
Every day 10,000 Europeans are diagnosed with heart failure and 15 million are estimated to live with the condition. Despite the prevalence, most people fail to recognize the symptoms, meaning many are misdiagnosed or incorrectly attribute the signs to growing older.
Entresto exhibits the mechanism of action of an 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)
