UK EAMS approves Entresto (sacubitril+valsartan) for heart failure- Novartis

According to the UK's Early Access to Medicines (EAMS) scheme, Entresto (sacubitril+valsartan), from Novartis, has been shown to reduce mortality and hospital admissions by reducing the risk of cardiovascular mortality and morbidity in adult patients with symptomatic heart failure and reduced ejection fraction. Thus the MHRA considered that it has the potential to offer significant benefits for patients with heart failure over current treatments and the UK will allow Novartis to roll out the drug under an early-access scheme, even though it has not received EMA approval.

The EAMS decision is based on the PARADIGM-HF trial, which found that in the group of patients receiving sacubitril/valsartan the percentage of patients who either died from cardiovascular causes or were admitted to hospital because of their heart failure (21.8%) was significantly lower than in the group of patients who received enalapril (26.5%). Also in general, fewer patients among those who received sacubitril/valsartan (17%) died from any cause compared with those who received enalapril (19.8%).

Comment: The drug won FDA approval a few months earlier and Novartis predicts peak sales at $5 billion, though some analysts predict as much as $10 billion annually.