The European Medicines Agency (EMA) has accepted to review The Medicines Company's marketing authorization application (MAA) for the investigational intravenous antiplatelet agent, cangrelor.
The filing is supported by the results of a comprehensive development programme, including the data from four randomized, double-blind clinical trials (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE) conducted in more than 25,000 patients with coronary artery disease. 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 MAA marks the beginning of the review process in the European Union for cangrelor. The Medicines Company announced July 1 the FDA accepted for review a New Drug Application (NDA) for cangrelor by the United States Food and Drug Administration (FDA).
"With the acceptance of the European filing, we look forward to working closely with the European Medicines Agency to advance the review process for cangrelor in Europe," said Simona Skerjanec, PharmD, MBA, senior vice president and innovation leader for Antiplatelet Therapies at The Medicines Company. "If the MAA review of cangrelor is successful, we anticipate the investigational product could be available to the European interventional cardiology community in 2015."
"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 Professor P Gabriel Steg, MD, of Hôpital Bichat in Paris and an investigator in the CHAMPION programme.
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting including in patients undergoing PCI.
The results of CHAMPION PHOENIX, a 11,145 patient phase III randomized, double-blind clinical trial comparing The Medicines Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing PCI were reported in March 2013.
In 2011, The Medicines Company also reported results of the BRIDGE trial, a prospective, randomized, double-blind, placebo-controlled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent that were at increased risk of thrombotic events following discontinuation of oral platelet inhibition prior to coronary artery bypass graft (CABG) surgery.
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care.