PARSIPPANY, NJ. --The Medicines Company today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the new drug application (NDA) for the Company's investigational intravenous antiplatelet cangrelor.

The filing was based on the results of a comprehensive development program, including the data from four randomized, double-blind clinical trials conducted in more than 25,000 patients with coronary artery disease (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE). Cangrelor is intended for use in patients undergoing percutaneous coronary intervention (PCI) and those that require bridging from oral antiplatelet therapy to surgery.

"There is a specific need for better antiplatelet solutions in patients being treated in the acute care setting and the clinical trial development program offers a clear look at data surrounding cangrelor's utility as an antiplatelet therapy in these patients," said Robert A. Harrington, MD, professor and chair of the Department of Medicine at Stanford and co-principal investigator of the CHAMPION program.

"With filing of the NDA now complete, we will work closely with the FDA to advance the review process for cangrelor during the next 10 months," said Simona Skerjanec, PharmD, MBA, Senior Vice President and Innovation Leader for Antiplatelet Therapies at The Medicines Company. "If the review is successful, we anticipate U.S. market approval in the second quarter of 2014. We remain on track for an anticipated European submission in the fourth quarter 2013."

The other co-principal investigator for the CHAMPION program, Deepak L. Bhatt, MD, MPH, chief of cardiology at VA Boston Healthcare System and Director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital, as well as professor of medicine at Harvard Medical School, added, "There is a wealth of data in the CHAMPION trials and we will continue analyzing it for the generation of future presentations at international forums, including the upcoming European Society of Cardiology."

Source: The Medicines Company