The FDA recently granted priority review to Novarits' investigational drug LCZ696, a potential treatment for heart failure with ejection fraction.
The FDA recently granted priority review to Novarits’ investigational drug LCZ696, a potential treatment for heart failure with ejection fraction (HFrEF).
LCZ was designed with a unique mechanism of action that boosts the heart’s protective neurohormonal systems while suppressing its more harmful systems, alleviating the strain on the heart.
Novartis submitted a New Drug Application for LCZ696 under the FDA’s Fast Track program, supporting the submission with data from a study comparing the drug with the common angiotensin-converting enzyme inhibitor, enalapril. The research team deemed twice-daily LCZ696 superior to enalapril in reducing the risk of cardiovascular death or heart failure-related hospitalization, as patients treated with LCZ696 reported better progress than those treated with enalapril.
LCZ696 maintained an acceptable safety profile throughout the trial.
“LCZ696 is a demonstration of our commitment to developing innovative medicines that improve important heart failure related outcomes such as cardiovascular mortality, hospitalization and quality of life,” said Novartis Pharmaceuticals Division Head David Epstein in a press release. “The FDA’s decision reflects the significant need to extend and improve life for HFrEF patients and Novartis is working to ensure LCZ696 can become available in the US as soon as possible.”
Given the reduced review time for drugs with priority review designation, the FDA could make a decision on LCZ696’s approval as early as August 2015.