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Novartis' new heart failure medicine recommended for EU approval

Published on 25/09/15 at 09:54am
Entresto 97/103mg tablets

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Novartis’s heart failure medication Entresto (sacubitril/valsartan), marking an important milestone towards it becoming available in the EU.

Pending final approval by the European Commission (EC), Entresto, previously known as LCZ696, will be available for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF).

"With the poor prognosis heart failure patients face - only half will be alive five years from diagnosis - the CHMP's endorsement of Entresto brings hope for HFrEF patients in Europe," says David Epstein, division head, Novartis Pharmaceuticals. "Already we're hearing about the benefits US doctors and HFrEF patients are experiencing with Entresto and hope to receive a final green-light from the EC soon."

The CHMP's decision follows previous US and Swiss approvals, and 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 hospitalised for heart failure than those given enalapril.

Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril. The most commonly-observed side effects include low blood pressure (hypotension), high blood potassium levels (hyperkalemia), and poor function of the kidneys (renal impairment).

Entresto was made available to patients in the UK under the Early Access to Medicines Scheme (EAMS) earlier this month.

The drug’s mechanism of action is as an Angiotensin Receptor Neprilysin Inhibitor that reduces the strain on the failing heart. The twice-a-day tablet enhances the protective neurohormonal systems of the heart while simultaneously suppressing the harmful system (the RAAS).

"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," says 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."

Hugh O’Dowd, General Manager at Novartis UK & Ireland, comments: “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.”

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 hospitalisations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact on quality of life.

Even though millions live with heart failure, most people fail to recognise the symptoms, meaning many are misdiagnosed or incorrectly attribute the signs to growing older.

Joel Levy

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