FDA Advisory Committee Recommends Approval of Cangrelor

April 15, 2015—The Medicines Company announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 9 to 2, with one abstention, to recommend approval of the investigational intravenous antiplatelet agent cangrelor as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural thrombotic events, such as myocardial infarction, stent thrombosis, and ischemia-driven revascularization.

Cangrelor is an immediately bioavailable and quickly reversible intravenous P2Y12 platelet inhibitor that was developed for the reduction of thrombotic cardiovascular events in patients with coronary artery disease undergoing PCI.

The Medicines Company advised that the CRDAC 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.

According to the company, CRDAC based its recommendation on the results of CHAMPION PHOENIX, a phase 3 randomized, double-blind clinical trial composed of 11,145 patients comparing the intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing PCI.

The CHAMPION PHOENIX study was lead by coprincipal investigators Deepak L. Bhatt, MD, and Robert A. Harrington, MD. Dr. Bhatt presented the results in March 2013 at the American College of Cardiology’s 62nd annual scientific session in San Francisco, California. The results were concurrently published in The New England Journal of Medicine (2013;368:1303–1313).

On March 30, 2015, the company announced that the European Commission granted marketing authorization for cangrelor. In markets that recognize CE Mark, cangrelor will be commercialized under the trade name Kengrexal. Cangrelor is not approved for commercial use in the United States, advised The Medicines Company.