Entresto (sacubitril valsartan) recommended by CHMP for EU approval

A positive review puts Entresto in a position to be approved for heart failure with reduced ejection fraction by the end of 2015 in the EU.

Entresto (sacubitril valsartan) recommended by CHMP for EU approval

Press Release Novartis – Frimley

Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Entresto™ (sacubitril valsartan). Pending final approval by the European Commission (EC), Entresto (sacubitril valsartan), previously known as LCZ696, will be licensed for use in the UK for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF).

“Despite widespread use of available treatments and implementation of NICE guidelines, outcomes remain poor for those diagnosed with heart failure. The CHMP’s endorsement of Entresto brings hope to heart failure patients in the UK,” said Hugh O’Dowd, General Manager at Novartis UK & Ireland.

The CHMP’s decision, which follows previous US and Swiss approvals, 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 (sacubitril valsartan) significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril1. At the end of the study patients who were given Entresto (sacubitril valsartan) were more likely to be alive and less likely to have been hospitalised for heart failure than those given enalapril. Analysis of safety data showed that Entresto (sacubitril valsartan) had a similar tolerability profile to enalapril.

“The striking results in the PARADIGM-HF trial led me to believe that, once approved, LCZ696 could quickly replace what has been the bedrock treatment for more than 20 years, ACE-inhibitors,” said Professor John McMurray of the University of Glasgow and one of two Principal Investigators. “Thousands of lives could be extended and hospital admissions prevented with LCZ696’s unique ability to boost natriuretic peptides, heart-helpful hormones, while simultaneously inhibiting the RAAS system.”

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 properly2. As a consequence, patients face a high risk of death, repeated hospitalisations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact quality of life. Heart failure affects around 550,000 people in the UK3 and costs the NHS about £2.3bn a year4. Even though so many people live with heart failure, most fail to recognise the symptoms, meaning many are misdiagnosed or incorrectly attribute the signs to growing older.

Early this month, Entresto (sacubitril valsartan) was given a positive scientific opinion under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) for patients with significant unmet medical need. This allows Entresto (sacubitril valsartan) to be made available to eligible patients before the EC makes a final European licensing decision based on the recommendations of the CHMP.

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For further information – Link to Novartis press release