Novartis’ breakthrough heart failure medicine LCZ696 receives FDA priority review

WASHINGTON - Feb. 17, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) has granted priority review for Novartis’ investigational medicine, LCZ69 to treat heart failure with reduced ejection fraction (HFrEF).  The accelerated review of LCZ696 will lessen the review time from 12 to 8 months which means the FDA could make an approval decision by August 2015.   "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 David Epstein, Division Head, Novartis Pharmaceuticals. "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."

The New Drug Application (NDA) was submitted based on LCZ696 being superior to ACE-inhibitor enalapril on key endpoints in the largest heart failure study ever done. According to the study patients reported they felt significantly better with LCZ696 vs enalapril thus maintaining an acceptable safety profile.

Heart failure affects approximately 5 million individuals in the Unites States and is one of leading causes of hospitalization. Based on the remarkable clinical results, industry analysts have helmed this treatment as the biggest breakthrough to treat heart failure in more than a decade.

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