EU Fast Tracks Novartis Cardio DrugBy
Novartis reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection fraction (HFrEF). The designation allows the CHMP to grant an opinion at day 150 versus a normal 210 day procedure, meaning a decision on European Union approval is expected within 2015.
Novartis requested accelerated assessment of LCZ696 in accordance with the EMA 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 authorization in the European Union in early 2015. In the US, LCZ696 has been granted Fast Track designation by the US Food and Drug Administration and a rolling submission is expected to be completed by the end of 2014.
LCZ696 is an ARNI (angiotensin receptor neprilysin inhibitor) and has a mode of action that 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), according to Novartis. The drug is a twice-a-day medicine being investigated for heart failure by acting 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% of patients dying within five years of a diagnosis of heart failure.