Heart failure with reduced ejection fraction: LCZ696, an angiotensin receptor - neprilysin inhibitor, granted FDA priority review
The FDA ( Food and Drug Administration ) has granted priority review designation to LCZ696, an 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.
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 ( Enapren ) on key endpoints, including significantly reducing the risk of cardiovascular 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 European Union ( EU ) the Committee for Medicinal Products for Human Use ( CHMP ) has granted accelerated assessment to LCZ696.
LCZ696, a twice a day medicine ( Valsartan / Sacubitril ) being investigated for heart failure, has a unique mode of action which is thought to reduce the strain on the failing heart. It acts to enhance the protective neurohormonal systems of the heart ( NP system ) while simultaneously suppressing the harmful system ( RAAS ).
Currently available medicines for HFrEF primarily block the harmful effects and mortality remains very high with up to 50% of patients dying within 5 years of a diagnosis of heart failure.
Heart failure is a debilitating and life-threatening disease; symptoms such as breathlessness, fatigue and fluid retention can appear slowly and worsen over time, significantly impacting quality of life.
It is a significant and growing public health concern with a high unmet need for new treatments. Every year, heart failure costs the world economy $108 billion, and hospitalizations comprise 60-70% of direct treatment costs. ( Xagena )
Source: Novartis, 2015