FDA grants priority review to Novartis heart-failure drug
Approximately 6 million people in the U.S. live with heart failure. Even with current treatments, approximately 50 percent of heart-failure patients die within five years of their diagnosis. Novartis said heart failure is a growing problem and that new, more-effective treatments are needed.
"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," David Epstein, a division head at Novartis Pharmaceuticals, said. "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 U.S. as soon as possible."
Priority review shortens the review period of medications that show promise in providing a substantial improvement in the effectiveness or safety of a diagnosis, treatment or prevention measures. Because of the designation, the review time for LCZ696 shrank from 12 to eight months.
Novartis submitted the New Drug Application (NDA) based on results from the PARADIGM-HF study, which showed that LCZ696 was more effective than ACE-inhibitors at reducing the risk of heart-failure hospitalization or heart-disease death. Patients from the study felt considerably better with LCZ696 than with enalapril, Novartis said.