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EMA committee grants accelerated assessment to Novartis’ LCZ696 for heart failure

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to Novartis' investigational medicine LCZ696, to treat patients with heart failure with reduced ejection fraction (HFrEF).

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The accelerated review procedure is granted infrequently by the EMA and so far it has not been awarded in the cardiovascular area.

The decision on European Union (EU) approval of this heart failure medicine LCZ696 is expected within 2015.

Novartis Pharmaceuticals division head David Epstein said: "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."

The company intends to submit marketing authorization in the EU in early 2015 and it will be based on results from the PARADIGM-HF study, which is claimed to be the largest ever conducted in heart failure.

The trial showed the twice a day medicine LCZ696 was superior to ACE-inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization.

The US Food and Drug Administration (FDA) has also granted fast track designation for LCZ696 and a rolling submission is expected to be complete by this year.

LCZ696 is an Angiotensin Receptor Neprilysin Inhibitor (ARNI) and it acts to improve the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).


Image: The decision on EU approval of this heart failure medicine LCZ696 is expected within 2015. Photo: courtesy of Andrew.