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FDA panel backs Medicines Co.'s Kengreal

April 16, 2015 2:23 AM UTC

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9-2 with one abstention to recommend approval of Kengreal cangrelor from The Medicines Co. (NASDAQ:MDCO) as an adjunct to percutaneous coronary intervention (PCI) to reduce risk of periprocedural ischemic complications including myocardial infarction (MI), stent thrombosis and ischemia driven revascularization. Kengreal, a reversible purinergic receptor P2Y G protein-coupled 12 ( P2RY12; P2Y12) antagonist, has a June 23 PDUFA date.

In briefing documents released ahead of the meeting, FDA reviewers supported the approval of Kengreal for the indication specifically in patients for whom treatment with an oral P2Y12 inhibitor prior to PCI is not feasible and when glycoprotein IIb/IIIa receptor antagonists are unlikely to be used (see BioCentury Extra, April 13). ...