Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection fraction (HFrEF). The expedited review procedure is granted infrequently by the EMA and has never been awarded in the cardiovascular area until now. The designation allows the CHMP to grant an opinion at day 150 versus a normal 210 day procedure, meaning a decision on EU approval is expected within 2015.

"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," said David Epstein, Division Head, Novartis Pharmaceuticals.

Novartis requested accelerated assessment of LCZ696 in accordance with the European Medicines Agency 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. The submission is planned to be based on results from the landmark PARADIGM-HF study, the largest ever conducted in heart failure, which showed LCZ696 was superior to ACE-inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization.

For more details, go to: http://www.novartis.com/newsroom/media-releases/en/2014/1874782.shtml