The Medicines Company has announced that the European Medicines Agency (EMA) has accepted for review a marketing authorisation application for the investigational intravenous antiplatelet agent cangrelor. The filing is supported by the results of a comprehensive development programme, including the data from four randomised, double-blind clinical trials (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE)
A press release reports that Cangrelor is in development for use in patients undergoing percutaneous coronary intervention (PCI) and those that require bridging from oral antiplatelet therapy to surgery.
The acceptance of the marketing authorisation application marks the beginning of the review process in the European Union for cangrelor. The Medicines Company announced in July last year (2013) that the FDA accepted for review a new drug application for cangrelor.
“There is a clear need for improved antiplatelet therapy for patients across Europe being treated in the acute cardiovascular care setting, and the cangrelor clinical programme provides a comprehensive look at the potential impact on clinical outcomes,” said P Gabriel Steg, of Hôpital Bichat in Paris and an investigator in the CHAMPION programme.