KengrealTreatment for Percutaneous Coronary Intervention
Update: Kengreal (cangrelor) Now FDA Approved - June 22, 2015
Totality of Data From Three Phase III Trials of The Medicines Company's Intravenous Cangrelor Presented and Published
AMSTERDAM, THE NETHERLANDS -- (Marketwired) -- 09/03/13 -- The Medicines Company (NASDAQ: MDCO) today reported presentation and publication of a pooled analysis of three Phase III clinical trials of an investigational intravenous (IV) antiplatelet, cangrelor. The trials compared IV cangrelor to either oral clopidogrel or placebo for prevention of thrombotic (clotting) complications during and after percutaneous coronary intervention (PCI). The findings of the pooled CHAMPION program confirm the results of the CHAMPION PHOENIX trial presented and published in April 2013.
This pre-specified, pooled analysis of patient-level data from CHAMPION-PCI, CHAMPION-PLATFORM, and CHAMPION-PHOENIX was presented at the European Society of Cardiology today and concurrently published in The Lancet.
Professor Christian Hamm, professor of internal medicine and cardiology and medical director of the Kerckhoff Heart and Thoraxcenter Bad Nauheim Germany, stated: "This is one of the largest Phase III programs ever conducted in patients undergoing PCI, an important consideration when evaluating the strength of the conclusions in the overall population and in study subgroups."
The totality of evidence in approximately 25,000 patients undergoing PCI demonstrates that cangrelor significantly reduced the odds of the primary composite endpoint of death, myocardial infarction (MI), ischemia-driven revascularization (IDR) or stent thrombosis (ST) at 48 hours after randomization by 19% (3.8% for cangrelor vs. 4.7% for control; OR 0.81, 95% CI 0.71-0.91, p=0.0007) and stent thrombosis by 41% (0.5% vs. 0.8%, OR 0.59, 95% CI 0.43-0.80, p=0.0008). "The findings were consistent across all analyzed subgroups of patients, including age, geography, diagnosis at presentation, and the choice of periprocedural anticoagulant, including more than 5,000 patients treated with bivalirudin," added CHAMPION programme co-chair Dr. Deepak L. Bhatt, professor of medicine at Harvard Medical School, chief of cardiology at VA Boston Healthcare System, and senior physician at Brigham and Women's Hospital.
"In addition, angiographic complications during the procedure were significantly reduced by cangrelor with a marked reduction in new or suspected thrombus, in acute stent thrombosis, and in the need for bailout glycoprotein IIb/IIIa inhibitor," stated CHAMPION programme co-chair Dr. Robert A. Harrington, professor of medicine at Stanford University and chairman of medicine at Stanford.
The pooled analysis also showed that the incidence of clinically important major bleeding as measured by GUSTO and TIMI bleeding scales was not increased with cangrelor. More sensitive measures showed an increase in bleeding with cangrelor, though there was no significant difference in the rate of transfusions. There were significantly more cases of transient dyspnea with cangrelor than with clopidogrel, a finding that was also observed in the individual CHAMPION studies.
"The results of this analysis provide a wealth of data that intravenous cangrelor reduces thrombotic events and importantly angiographic complications during the procedure, a totality of evidence that will have impact on guideline recommendations," said Professor Phillipe Gabriel Steg, professor of cardiology; director, Coronary Care Unit Hôpital. Bichat-Claude Bernard, Paris, France.
Simona Skerjanec, PharmD, MBA, Senior Vice President and Innovation Leader for Antiplatelet Therapies at The Medicines Company confirmed, "As previously stated we are currently working with the Food and Drug Administration to progress the US filing and we are on track to file in Europe as planned in Q4 2013."
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 percutaneous coronary intervention (PCI).
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.
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" 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 products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, 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, risks associated with the establishment of international operations, whether the Company is able to obtain or maintain patent protection for the intellectual property relating to the Company's products; 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 August 9, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Source: The Medicines Company
Posted: September 2013
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