PARSIPPANY, NJ -- (Marketwired) -- 02/12/14 --
The Medicines Company (NASDAQ: MDCO) announced today that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted to recommend against approval of the intravenous antiplatelet agent cangrelor for use in patients undergoing percutaneous coronary intervention (PCI) -- or cardiac stent procedures -- or those that require bridging from oral antiplatelet therapy to surgery.
The committee recommendation is not binding on the FDA, which makes the final decision on approval. The Prescription Drug User Fee Act (PDUFA) goal date for the cangrelor new drug application (NDA) is April 30, 2014.
"Although we are disappointed by the Committee's decision, we appreciate the dialogue during today's meeting and look forward to subsequent discussion with the FDA," said Clive A. Meanwell, MD, PhD, the company's Chairman and Chief Executive Officer. "We continue to believe in the safety and efficacy of cangrelor and look forward to working with the Agency as it completes its review."
The cangrelor NDA and presentations before the Committee focused on 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 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, an 11,145 patient Phase 3 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.
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: acute cardiovascular care, surgery and perioperative care, and serious infectious disease 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," "plans, "anticipates" and "expects" 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 the Company's 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 Quarterly Report on Form 10-Q filed on November 5, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Neera Dahiya Ravindran, MD
Vice President, Investor Relations & Strategic Planning
The Medicines Company
+1 (973) 290-6044
Source: The Medicines Company