BASEL (dpa-AFX) - Swiss pharmaceutical giant Novartis AG (NVS) said the Committee for Medicinal Products for Human Use or CHMP has granted accelerated assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection fraction or HfrEF.
According to the company, 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 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.
In the U.S., LCZ696 has been granted Fast Track designation by the FDA and a rolling submission is expected to be complete by the end of 2014.
Copyright RTT News/dpa-AFX