Novartis recently announced that Entresto (sacubitril/valsartan) has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP). The decision is an important step in Entresto becoming available in the European Union. The final approval by the European Commission (EC) is pending.
Entresto, known previously as LCZ696, is a drug designed for the treatment of adults with symptomatic chronic heart failure, a serious, life-threatening condition that occurs when the heart is no longer able to pump blood efficiently, and reduced ejection fraction (HFrEF), also referred to as systolic heart failure, a condition where the heart does not contract effectively. Patients with heart failure may experience a shortness of breath, persistent coughing, heart palpitations, swelling or weight gain, fatigue, memory loss and disorientation, being also at a higher risk of repeated hospitalizations and death.
Entresto is a twice-a-day tablet able to enhance the protective neuro-hormonal systems of the heart, reducing tension on a failing heart.
“With the poor prognosis heart failure patients face – only half will be alive 5 years from diagnosis – the CHMP’s endorsement of Entresto brings hope for HFrEF patients in Europe,” said the Division Head at Novartis Pharmaceuticals, David Epstein in a press release. “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.”
Entresto is already approved in the United States and Switzerland. Now, the positive CHMP decision was based on the world’s largest heart failure clinical trial (PARADIGM-HF study) with 8,442 patients, where Entresto was shown to significantly reduce heart failure hospitalizations and the risk of cardiovascular death.
“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 one of the Principal Investigators of the trial, Professor John McMurray of the University of Glasgow. “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 [the harmful renin-angiotensin-aldosterone system].”
It is estimated that 10,000 Europeans are diagnosed with heart failure every day, and that 15 million currently live with the condition. Novartis hopes to obtain the final European approval for Entresto by the end of the year.