Investigational Heart Failure Therapy Granted Priority Review
Novartis announced that the Food and Drug Administration (FDA) has granted Priority Review to its New Drug Application (NDA) for LCZ696 for the treatment of heart failure with reduced ejection fraction (HFrEF).
The NDA submission was based on results from the landmark PARADIGM-HF study. The study demonstrated that LCZ696 was superior to the accepted guideline therapy ACE-inhibitor enalapril on key endpoints, including the primary endpoint, which showed reduction of the risk of either cardiovascular death or heart failure hospitalization by 20%.
LCZ696 is the first in a new class of medicines called Angiotensin Receptor Neprilysin Inhibitors (ARNI) which act in multiple ways on the neurohormonal systems of the heart. LCZ696 blocks receptors exerting harmful effects while simultaneously promoting protective mechanisms. It is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover.
For more information call (800) 693-9993 or visit Novartis.com.