FDA Priority review for new ARNI heart failure drugNews - Feb. 19, 2015
The US Food and Drug Administration (FDA) has granted priority review designation to LCZ696, the investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF). The designation accelerates the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. For LCZ696 this reduces the total review time from 12 to 8 months, meaning the FDA could make a decision on approval in August 2015.
LCZ696 is a combination of the angiotensin receptor blocker valsartan and a neprilysin inhibitor, yielding a unique two-way mode of action by enhancing the protective neurohormonal systems of the heart and simultaneously suppressing the RAAS system.
The New Drug Application (NDA) was submitted under the agency's Fast Track program and is based on results from the landmark PARADIGM-HF study, the largest ever conducted in heart failure, which showed LCZ696 was superior to ACE-inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. Patients' reports of how well they felt were significantly better with LCZ696 than enalapril, whilst maintaining an acceptable safety profile.
In the EU the Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ696.
Press release Novartis February 13 2015