Novartis' Heart Failure Drug Awarded Speedy Review By CHMP

Basel-based Novartis reported that it has received accelerated assessment from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its investigational drug LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF).

LCZ696 is a twice daily treatment for heart failure that acts to improve the protective neurohormonal systems of the heart (NP system) while at the same time suppressing its harmful system known as renin-angiotensin-aldosterone system (RAAS). The drug is an ARNI (Angiotensin Receptor Neprilysin Inhibitor) that possesses a novel mode of action thought to reduce the strain on a failing heart. LCZ696 has received Fast Track status from the U.S. Food and Drug Administration (FDA), which makes it eligible for a rolling submission that is expected to be completed by the end of this year.

Heart failure is a deadly and disabling disease characterized by fatigue, breathlessness, and fluid retention that significantly builds up and worsens as the disease progresses. Current treatments for heart failure tend to focus only on blocking the RAAS. Up to 50 percent of patients succumb to heart failure within 5 years of diagnosis.

The accelerated assessment from the CHMP cuts its review process from the standard 210 to 150 days, moving an expected EU approval decision within 2015. David Epstein, Division Head of Novartis Pharmaceutical, 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 said it expects to file the Marketing Authorization Application (MAA) for LCZ696 in early 2015 in the EU. The submission will be supported by results from the PARADIGM-HF study showing that the drug demonstrated superiority to ACE-inhibitor enalapril on key endpoints, such as significant risk reduction of CV death or hospitalization due to heart failure. Earlier this year, Novartis closed the late-stage study early thanks to strong interim results of the drug’s performance.