ARTICLE | Clinical News

Novartis stops heart failure trial early for efficacy

March 31, 2014 11:42 PM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) stopped early the 8,436-patient Phase III PARADIGM-HF trial of twice-daily LCZ696 to treat heart failure in patients with reduced ejection fraction (HF-REF). An interim analysis showed the product met the primary endpoint of a composite of time to first occurrence of cardiovascular death or heart failure hospitalization vs. standard of care with twice-daily enalapril.

Novartis said it will start discussions with worldwide regulatory authorities for LCZ696, but declined to disclose details. In January, the pharma said it planned to submit regulatory applications this year. The compound is a dual inhibitor of angiotensin II type 2 (AT2) receptor (ATGR2) and neutral endopeptidase ( neprilysin; MME; NEP; CD10). ...