The Medicines Company's Cangrelor Approved in Europe

March 30, 2015—The Medicines Company announced that the European Commission has granted marketing authorization for Kengrexal (cangrelor). The approval comes after the issuance of positive opinions in January by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

Kengrexal is a bioavailable and quickly reversible intravenous small molecule antiplatelet agent that is used to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing percutaneous coronary intervention (PCI).

The company advised that the European Medicines Agency submission for Kengrexal was supported by the results from the CHAMPION PHOENIX trial, which provided the primary evidence of efficacy for the PCI indication for the drug. CHAMPION PHOENIX is an 11,145-patient, phase 3, randomized, double-blind clinical trial comparing Kengrexal to oral clopidogrel in patients undergoing PCI.

The CHAMPION PHOENIX results were reported by Deepak L. Bhatt, MD, in March 2013 at the American College of Cardiology’s 62nd annual scientific session and published concurrently in The New England Journal of Medicine (2013;368:1303–1313). Data from the CHAMPION-pooled population of more than 25,000 PCI patients provide additional clinical support for safety.

In The Medicines Company’s announcement, Prof. Philippe Gabriel Steg, MD, commented, “The availability of a potent, injectable, and reversible antiplatelet agent will be an important adjunct to our therapeutic armamentarium to reduce periprocedural complications and help make PCI safer. It will be useful in a variety of settings from acute myocardial infarction to elective PCI, mostly in patients in whom antiplatelet agents have either not been administered or are known to be poorly effective.” Prof. Steg is Director of the Coronary Care Unit at Hôpital Bichat-Claude Bernard in Paris, France.

Cangrelor is not approved for commercial use in the United States. A new drug application for cangrelor under the trade name Kengreal is under active review by the US Food and Drug Administration, advised the company.