The US Food and Drug Administration (FDA) has granted priority review designation to Novartis' 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. 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 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 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.

LCZ696, a twice a day medicine 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 (the 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 in which the heart cannot pump enough blood around the body. 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, HF costs the world economy $108 billion, and hospitalizations comprise 60-70% of direct treatment costs.