An FDA advisory panel recommended the approval of cangrelor to reduce the risk of periprocedural thrombotic events in patients with coronary artery disease undergoing PCI.
On April 15, the Cardiovascular and Renal Drugs Advisory Committee voted 9-2 in favor of the approval. One member abstained. On Feb. 12, 2014, the committee voted 7-2 against approving cangrelor (Kengreal, The Medicines Company), which is an intravenous P2Y12 platelet inhibitor.
The Medicines Company said in a news release that it expected the FDA to make its new drug application decision by June 23.
The recommendation for approval was based on results of CHAMPION PHOENIX, a randomized, double-blind trial that enrolled 11,145 patients and compared cangrelor with clopidogrel. CHAMPION PHOENIX, presented at ACC.13, found that cangrelor significantly reduced the rate of ischemic events, including stent thrombosis, during PCI, with no significant increase in severe bleeding.
The FDA often but not always follows the recommendation of its advisory committees.