The European Commission (EC) has granted marketing authorisation to Entresto (sacubitril/valsartan), according to a press release from Novartis. The product has been authorised for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).
This authorisation follows the results from the PARADIGM-HF study, which compared sacubitril/valsartan and the ACE-inhibitor enalapril in 8,442 patients with HFrEF. The trial was stopped prematurely when sacubitril/valsartan was shown to significantly reduce the risk of cardiovascular death. Sacubitril/valsartan was shown to be superioir to enalapril in reducing the risks of mortality and of hospitalisation for heart failure. Analysis of safety data showed that both drugs had a similar tolerability profile.
Dimitrios Georgiopoulos, chief scientific officer, Novartis Pharmaceuticals, UK says, “Sacubitril/valsartan is a new first-in-class treatment option for heart failure patients with reduced ejection fraction that demonstrated a significant mortality benefit, including reducing the risk of sudden death versus, the current standard of care.”
Novartis is currently preparing for sacubitril/valsartan to be available in the UK before the end of 2015. Since September 2015, sacubitril/valsartan has been available to patients under the Early Access to Medicines Scheme (EAMS). Patients who are currently receiving sacubitril/valsartan under EAMS will continue to do so until the Health Technology Assessment completes its appraisal of the medicine, anticipated in 2016. No new patients, however, will be able to receive sacubitril/valsartan under EAMS now that it has received European marketing authorisation.
Novartis is working with NICE and the Scottish Medicines Consortium (SMC) to ensure that sacubitril/valsartan will be available to as many eligible patients as once it has been appraised.