The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment status to Novartis’ investigational heart failure drug, LCZ696.
The new heart failure drug, intended for patients with heart failure with reduced ejection fraction, is to benefit from an accelerated European review process which will allow the CHMP to grant an opinion after 150 days instead of the normal 210.
Accelerated review status is seldom granted and has never before been awarded to a cardiovascular therapy. A decision on EU approval is now expected to arrive during 2015.
The regulatory submission will be based on results from the largest ever landmark study conducted in heart failure, PARADIGM-HF. The results showed that LCZ696 can significantly reduce the risk of cardiovascular death or heart failure hospitalisation compared to an established alternative.
David Epstein, division head of Novartis Pharmaceuticals, 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.”