Healthcare Industry News: bivalirudin
News Release - October 30, 2013
The Medicines Company's EUROMAX Trial of Angiox(R) (Bivalirudin) in Heart Attack Meets All Prespecified EndpointsPositive Results of Phase IIIb Trial of Angiox Started in Emergency Transport of STEMI Patients Undergoing Primary PCI; 30 Day Results Presented at TCT and Simultaneously Published in The New England Journal of Medicine; Primary Endpoint of Death and Major Bleeding Reduced Significantly
SAN FRANCISCO, CA--(Healthcare Sales & Marketing Network) - The Medicines Company (NASDAQ: MDCO) today announced results from the EUROMAX Trial, a 2,218 patient Phase IIIb randomized study of the Company's Angiox« (bivalirudin), which is marketed as Angiomax« (bivalirudin) in the US. The trial met its pre-specified primary and secondary endpoints, including statistically significant reductions in the primary composite endpoint of death and major bleeding among patients randomized to Angiox. Results were presented as a Late-Breaking Clinical Trial at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium and were published simultaneously in The New England Journal of Medicine.
The EUROMAX trial compared administration of Angiox to heparin or low-molecular weight heparin (heparins) with optional glycoprotein inhibitors (GPI) started during emergency transport in patients with STEMI, the most severe form of heart attack, undergoing primary percutaneous coronary intervention (PCI).
Patients treated with Angiox vs. heparins showed a:
40% relative risk reduction (5.1% vs. 8.5%, p=0.001) in the primary composite endpoint of death and non-CABG related bleeding 30 days after their PCI
28% relative risk reduction in the principal secondary composite outcomes of death, re-infarction or major bleeding (6.6% vs. 9.2%, p=0.02)
57% relative risk reduction of major bleeding (2.6% vs. 6.0%, p
Principal Investigator, lead author and presenter, Professor P. Gabriel Steg, MD, of H˘pital Bichat in Paris, said, "EUROMAX was a large, international, randomized trial in AMI management with early triage and initiation of therapy, in a contemporary treatment setting in which half the patients underwent PCI via the radial access approach and received either prasugrel or ticagrelor, one of the new P2Y12 inhibitors. These results pave the way for routine use of bivalirudin as an anticoagulant during the pre-hospital phase of acute myocardial infarction management, during transport of patients for emergency primary angioplasty."
Efthymios N. Deliargyris, MD, Vice President and Global Medical Director of The Medicines Company, said, ''EUROMAX provides further evidence of the clinical utility of Angiox in contemporary PCI for acute myocardial infarction, with results highly consistent with the observations from the HORIZONS-AMI trial."
The risk of acute stent thrombosis was higher in patients treated with bivalirudin vs. heparins (1.1% vs. 0.2%; relative risk, 6.11, p = 0.007). The investigators noted in The New England Journal of Medicine paper, ''Given the delayed onset of the anti-platelet effect of the oral P2Y12 inhibitors in STEMI, avoiding the occurrence of stent thrombosis may require more potent and rapidly effective anti-thrombotic agents, such as intravenous anti-platelet drugs."
Simona Skerjanec, Senior Vice President of Cardiovascular Medicines at The Medicines Company, added, ''EUROMAX demonstrates our ongoing efforts to perform rigorous clinical trials and demonstrates our commitment to advancing acute cardiovascular care globally to save lives, alleviate suffering and contribute to the economics of healthcare."
EUROMAX (EUROpean aMbulance Acs angioX trial) is a 2,218 randomized, controlled, open label, international, multicenter study that compared early administration of Angiox to unfractionated or low-molecular-weight heparin with optional glycoprotein inhibitors (GPI). Patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary percutaneous coronary intervention (PCI) received either bivalirudin or unfractionated or low-molecular-weight heparin with optional GPI (control group). At 30 days, the primary outcome was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. Patients who were assigned to the bivalirudin group received a bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour, which should be continued for at least 4 hours after PCI. The protocol also specified that the dose during the post-PCI interval should be 0.25 mg per kilogram per hour; however, continuation of the higher dose used during PCI was also permitted. Bailout use of a GPI was allowed in the event of giant thrombus or no-reflow.
In Europe, Angiox currently is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-STEMI planned for urgent or early intervention. Please see full prescribing information available at http://www.angiox.com.
In the United States, bivalirudin is marketed under the trade name Angiomax and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
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 infection 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" 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 physicians, patients and other key decision makers will accept clinical trial results, the extent of the commercial success of Angiox, the Company's ability to develop its global operations and penetrate foreign markets, risks associated with the establishment of global operations, whether clinical trial results will warrant submission of applications for regulatory approval, including for additional patient populations, whether the Company will make regulatory submissions for product candidates on a timely basis, whether the Company's regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, 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 Registration Statement on Form S-3 filed on August 12, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Source: The Medicines Company
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