Novartis wins US nod for new heart drug
pharmafile | July 8, 2015 | News story | Research and Development, Sales and Marketing | Entestro, FDA, LCZ696, Novartis, ejection fraction, heart failure, reduced ejection fraction, sacubitril
The FDA has given the green light to Novartis’ new heart failure drug, six weeks ahead of the scheduled date for its priority review.
The US regulator approved Entresto, (sacubitril/valsartan), which has previously been known as LCZ696, for the treatment of people with heart failure with reduced ejection fraction – a measurement of how well the heart is pumping. It is caused by other conditions that damage the heart, such as heart attacks and high blood pressure.
Entresto will be available on prescription for some people with heart failure, to reduce their risk of dying from heart problems or having to go to hospital for heart failure symptoms. It is usually given along with other heart failure therapies, in place of other heart drugs called ACE inhibitors or angiotensin receptor blockers.
“Heart failure is a leading cause of death and disability in adults,” says Dr Norman Stockbridge, who is director of the division of cardiovascular and renal products in the FDA’s center for drug evaluation and research. “Treatment can help people with heart failure live longer and enjoy more active lives.”
The FDA’s decision is based on results from a large Novartis-backed study in more than 8,000 people with heart failure. It showed Entresto significantly reduced the risk of death from heart problems compared to the ACE inhibitor enalapril.
At the end of the study, patients with impaired ejection fraction who were given Entresto were more likely to be alive and less likely to have been in hospital for heart failure than those given enalapril.
David Epstein, division head at Novartis pharmaceuticals says: “Despite the uncertainty and high financial risk we designed the world’s largest heart failure trial to compare Entresto to the previous gold standard.
“As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital. We recognise our responsibility to ensure Entresto reaches US patients and prescribers as soon as possible and will begin shipping in the US in the coming week.”
And Dr Milton Packer, professor and chair for the department of clinical sciences at the University of Texas Southwestern medical center, says he believes Entresto will “change the management of patients with heart failure with reduced ejection fraction for years to come.”
Novartis is awaiting further regulatory decisions in Canada, Switzerland and Europe later this year. In the UK, the drug has been awarded Promising Innovative Medicines status by the MHRA – the first of two steps required for inclusion in the Early Access to Medicines Scheme.
Lilian Anekwe
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