Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection fraction (HFrEF). The expedited review procedure is granted infrequently by the EMA and has never been awarded in the cardiovascular area until now. The designation allows the CHMP to grant an opinion at day 150 versus a normal 210 day procedure, meaning a decision on EU approval is expected within 2015.
"Novartis is committed to extending and improving more lives sooner with LCZ696, and this decision by the CHMP we hope will greatly support our effort to do so in Europe," said David Epstein, Division Head, Novartis Pharmaceuticals.
Novartis requested accelerated assessment of LCZ696 in accordance with the European Medicines Agency regulations that it may be justified for 'medicinal products of major interest from the point of view of public health and in particular from the view point of therapeutic innovation'.
Novartis expects to submit the file for marketing authorisation in the European Union in early 2015. The submission is planned to be 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.
In the US LCZ696 has been granted Fast Track designation by the FDA and a rolling submission is expected to be complete by the end of 2014.
LCZ696, a twice a day medicine being investigated for heart failure, 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 only block the harmful effects and mortality remains very high with up to 50 per cent of patients dying within 5 years of a diagnosis of heart failure.
LCZ696 is an ARNI (Angiotensin Receptor Neprilysin Inhibitor) and has a unique mode of action which is thought to reduce the strain on the failing heart. It harnesses the body's natural defenses against heart failure, simultaneously acting to enhance the levels of natriuretic and other endogenous vasoactive peptides, while also inhibiting the renin-angiotensin-aldosterone system (RAAS).
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, the total cost of heart failure (HFrEF and HFpEF) to the worldwide economy is $108 billion, and hospitalisations comprise 60-70 per cent of treatment costs.