Novartis’ new heart failure drug to receive accelerated EU review

Novartis has announced that its new heart failure drug LCZ696 is to benefit from an accelerated European review process.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment status to the investigational medicine, which is intended for patients with heart failure with reduced ejection fraction.

It will allow the CHMP to grant an opinion after 150 days instead of the normal 210, meaning a decision on EU approval is expected within 2015. Accelerated review status is rarely granted and has never been awarded to a cardiovascular therapy before.

The regulatory submission will be based on results from the landmark PARADIGM-HF study, the largest ever conducted in heart failure, which showed 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."

Earlier this week, the company's Signifor therapy was ratified in Europe as a treatment for acromegaly, while the psoriasis therapy Cosentyx was recommended for approval by the CHMP.