EU approves Kengrexal for PCI - The Medicines Co
The European Commission has granted marketing authorization for Kengrexal (cangrelor), from The Medicines Co., for patients with heart disease needing percutaneous intervention. The Marketing Authorization Application (MAA) submission for Kengrexal to the EMA was based on the results from the CHAMPION PHOENIX trial, which provided the primary evidence of efficacy for the PCI indication for Kengrexal.
The results of CHAMPION PHOENIX, an 11,145 patient Phase III randomized, double-blind clinical trial comparing Kengrexal to oral clopidogrel in patients undergoing PCI were reported in March 2013. Data from the CHAMPION-pooled population of over 25,000 PCI patients provide additional clinical support for safety.
Learning Zones
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