New heart failure drug gets European approval

16th December 2015

The new heart failure drug Entresto, the twice-a-day sacubitril and valsartan pill formerly known as LCZ696, has been given the go-ahead in Europe.

The drug's maker Novartis says the  European Commission has approved the drug for treating people with chronic heart failure and a reduced ejection fraction (a measurement of how effectively the heart is pumping). This follows approval of the drug in America in July.

The medical community has been anticipating the introduction of Entresto since trial results last year, says the company.

The trial was stopped early because of a significant cut in lost lives in the group taking the new drug compared to those on the ACE inhibitor enalapril.

Final results of the trial showed that treatment with Entresto resulted in a significant reduction in deaths from all causes and hospital admissions for heart failure.

Researchers estimate it will give people with heart failure an extra one or two years on the ten or more years they are currently expected to live.

They estimate that for a 55-year-old, survival would increase from 11.6 years to 12.9 years.  The mean for avoiding death or a hospital admission was 2.1 years

For a 65-year-old, life expectancy would increase from 10 years to 11.4 years.  Extra survival for 75-year-olds was 1.1 years and for 80 year-olds an extra 0.2 years.

Dr Sanjay Kaul, from the Cedars-Sinai Hospital in Los Angeles, said the results were especially impressive since it was an active controlled trial. "It is important to keep in mind that the treatment benefit relative to placebo would be greater," he said.

Dr Kaul pointed to one important limitation of the study, which assumed that the benefit of sacubitril-valsartan treatment would remain consistent with long-term use. So far follow up had been 34 months.

Professor Perry Elliott, from Barts Heart Centre in London, said that regulatory bodies and professional societies were drawing up guidelines for the use of the drug. He thought that in the UK the drug would be initially recommended for people with heart failure who are not responding to conventional therapy and have similar characteristics to people in the trial. But the medical community would know for certain in the new year.