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FDA reviewers back narrowed cangrelor indication
April 14, 2015 2:25 AM UTC
In 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) and stent thrombosis in certain patients. Kengreal's PDUFA date is June 23.
The reviewers recommended the injectable therapy to treat 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. ...