FDA Advisory Committee Recommends Approval of The Medicines Company's Antiplatelet Therapy Cangrelor

The Medicines Company

announced today that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 9 - 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 (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 the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing PCI. "We are grateful for the recommendation of this Committee and appreciate the thorough review of our data for cangrelor," said Loretta Itri, MD, Executive Vice President, Global Health Science and Regulatory, The Medicines Company. "We look forward to continuing to work with the FDA in the coming weeks to bring this product to patients."