The Committee recommendation is not binding on the FDA, which makes the final decision regarding approval and the indication and labeling. The Company expects the FDA to complete its review of the NDA by June 23, 2015.
The Committee based its recommendation on the results of CHAMPION PHOENIX, an 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing PCI.
"We are grateful for the recommendation of this Committee and appreciate the thorough review of our data for cangrelor," said Loretta Itri, MD, Executive Vice President, Global Health Science and Regulatory, The Medicines Company. "We look forward to continuing to work with the FDA in the coming weeks to bring this product to patients."
Cangrelor is an immediately bioavailable and quickly reversible intravenous P2Y12 platelet inhibitor under development for the reduction of thrombotic cardiovascular events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). Cangrelor is not approved for commercial use in the United States. In March 2015, the European Commission granted marketing authorization for cangrelor, which will be marketed under the trade name KENGREXAL™.
The CHAMPION PHOENIX study provided the primary evidence of efficacy for the proposed PCI indication for cangrelor. The results of PHOENIX, an 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company's cangrelor to oral clopidogrel in patients undergoing PCI, were reported in March 2013.
Cangrelor can increase the risk of bleeding. The most common adverse reaction in clinical trials was bleeding (15.5%). In CHAMPION PHOENIX severe/life-threatening, moderate and mild bleeding events were more common with cangrelor than with clopidogrel and dyspnea was reported more frequently in patients treated with cangrelor than with clopidogrel.
About The Medicines Company
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: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," "hopes" and "potential" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-K filed with the SEC on March 2, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.