Entresto, the novel heart failure drug from Novartis, has now been approved in Europe. The company said the drug, a twice-a-day combination of sacubitril and valsartan (formerly known as LCZ 696), had been approved by the European Commission for the treatment of people with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).
The news follows previous approval of the drug by the FDA in the US in July.
The medical community has been anticipating the introduction of Entresto since the results of the PARADIGM-HF trial became known last year. The trial, which compared Entresto to enalapril in 8,442 heart failure patients, was stopped early because of a significant reduction in cardiovascular mortality in the group taking the new drug. Final results of the trial showed that treatment with Entresto resulted in a significant reduction in all-cause mortality as well as a significant reduction in the combined endpoint of cardiovascular death or hospitalization for heart failure.
Novartis said that 15 million people in Europe have heart failure, with 10,000 new patients being diagnosed every day. Novartis did not disclose what the drug will cost in Europe. The cost of the drug in the US is $12.50 per day before discounts.