Novartis' heart failure medicine LCZ696 granted accelerated assessment by CHMP in Europe[1]

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• Decision by EU review body could speed access to LCZ696 for HFrEF patients in the EU
   

LCZ696 is the first investigational cardiovascular drug to be granted accelerated assessment, shortening the formal review clock by 60 days[2]
 

Approximately 15 million people in the EU live with heart failure, facing a high risk of death and poor quality of life, despite currently available medicines[3]

Basel, November 28, 2014 - 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.

In the US LCZ696 has been granted Fast Track designation by the FDA and a rolling submission is expected to be complete by the end of 2014.

About LCZ696 in heart failure
LCZ696, a twice a day medicine being investigated for heart failure, acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS). Currently available medicines for HFrEF only block the harmful effects and mortality remains very high with up to 50% of patients dying within 5 years of a diagnosis of heart failure[4],[5],[6].