Kengreal Cangrelor regulatory update

FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2, with 1 abstention, to recommend approval of Kengreal cangrelor from The Medicines Co. 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. The PDUFA date is June 23. The product is a reversible purinergic receptor P2Y G protein-coupled 12 ( P2RY12; P2Y12) antagonist.

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. ...