The FDA has granted priority review for Novartis's LCZ-696, a combination of the neprilysin inhibitor sacubitril and the angiotensin AT1 receptor antagonist valsartan, for the treatment of heart failure with reduced ejection fraction (HFrEF).
The action date for review is in August 2015. The NDA contains data from the double-blind phase III trial PARADIGM-HF, in which approximately 8,456 patients with chronic heart failure and reduced ejection fraction received LCZ-696 at 200 mg twice daily or enalapril 10 mg twice daily (ClinicalTrials.gov Identifier NCT01035255).
The trial was stopped early because LCZ-696 showed significant benefit compared to enalapril, including a 20% reduction in the risk of cardiovascular death or heart failure hospitalization.The EMA's Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ-696. Novartis expects to file an MAA in early 2015 (Novartis News Release; ClinicalTrials.gov Web site).