April 29, 2015 — The Medicines Company announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9 - 2 with one abstention to recommend approval of the investigational intravenous antiplatelet agent cangrelor as an adjunct to percutaneous coronary intervention (PCI). Cangrelor is indicated for reducing the risk of periprocedural thrombotic events such as myocardial infarction (MI), stent thrombosis (ST) and ischemia-driven revascularization.
The Committee recommendation is not binding on the FDA, which makes the final decision regarding approval and the indication and labeling. The company expects the FDA to complete its review of the NDA by June 23, 2015.
The Committee based its recommendation on the results of CHAMPION PHOENIX, an 11,145-patient Phase 3 randomized, double-blind clinical trial comparing cangrelor to oral clopidogrel in patients undergoing PCI.
Cangrelor is an immediately bioavailable and quickly reversible intravenous P2Y12 platelet inhibitor under development for the reduction of thrombotic cardiovascular events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). Cangrelor is not approved for commercial use in the United States. In March 2015, the European Commission granted marketing authorization for cangrelor, which will be marketed under the trade name Kengrexal.
The CHAMPION PHOENIX study provided the primary evidence of efficacy for the proposed PCI indication for cangrelor. The results of PHOENIX were reported in March 2013.
Cangrelor can increase the risk of bleeding. The most common adverse reaction in clinical trials was bleeding (15.5 percent). In CHAMPION PHOENIX severe/life-threatening, moderate and mild bleeding events were more common with cangrelor than with clopidogrel and dyspnea was reported more frequently in patients treated with cangrelor than with clopidogrel.
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