EU approval for new heart failure drug
The approval is based on results from the PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown that sacubitril/valsartan (previously known as LCZ696) significantly reduced the risk of cardiovascular death versus the ACE-inhibitor enalapril. At the end of the study patients who were given sacubitril/valsartan were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that sacubitril/valsartan had a similar tolerability profile to enalapril.
Results from the 8,442 patient PARADIGM-HF study showed, versus enalapril, sacubitril/valsartan:
- reduced the risk of death from cardiovascular causes by 20%
- reduced heart failure hospitalizations by 21%
- reduced the risk of all-cause mortality by 16%
Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or time to first heart failure hospitalization.
Fewer patients on sacubitril/valsartan discontinued study medication for any adverse event compared to those on enalapril. The sacubitril/valsartan group had more hypotension and non-serious angioedema but less renal impairment, hyperkalemia and cough than the enalapril group.
Press release Novartis, November 24, 2015