The Medicines Company has announced that it has received the CE mark for cangrelor (Kangrexal)—the first and only intravenous antiplatelet agent that provides immediate, consistent, and rapidly reversible P2Y12 inhibition. The company also announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9–2, with one abstention, to recommend approval of the drug.
According to a press release, cangrelor is the first and only immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing percutaneous coronary intervention (PCI). Philippe Gabriel Steg (director of the Coronary Care Unit, Hôpital Bichat-Claude Bernard, Paris, France) says about drug receiving the CE mark, “The availability of a potent, injectable, and reversible antiplatelet agent will be an important adjunct to our therapeutic armamentarium to reduce peri-procedural 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.”
The Marketing Authorization Application (MAA) submission for cangreglor was based on the results from the CHAMPION PHOENIX trial, which provided the primary evidence of efficacy for the PCI indication for the drug. The results of CHAMPION PHOENIX, an 11,145 patient Phase 3 randomised, double-blind clinical trial comparing cangreglor to oral clopidogrel in patients undergoing PCI were reported in March 2013. Data from the CHAMPION-pooled population of over 25,000 PCI patients provide additional clinical support for safety.
The FDA committee recommendation is not binding on the FDA, which makes the final decision regarding approval and the indication and labelling. The Medicines Company expects the FDA to complete its review of the new drug application by June 23, 2015.