Healthcare Industry News: bivalirudin
News Release - August 28, 2012
Latest European Heart Attack Treatment Guidelines Recommend Angiomax(R)/Angiox(R) (Bivalirudin) Over HeparinMUNICH, GERMANY--(Healthcare Sales & Marketing Network)- Updated treatment guidelines presented by a leading European acute cardiology expert task force on the management of a severe form of heart attack called ST-segment elevation acute myocardial infarction (STEMI) recommend the use of bivalirudin (The Medicines Company (MDCO) trade name Angiox® in Europe and Angiomax® in North America and Asia) over heparin and a GP IIb/ IIIa blocker.
According to the guidelines, an anticoagulant "must be used" in patients undergoing primary percutaneous coronary intervention (PCI), an emergency lifesaving procedure used to unblock coronary arteries and restore blood flow to the heart muscle in a heart attack. The experts nominated Angiox as the Class I first choice "recommended over unfractionated heparin and a GP IIb/IIIa blocker."
The guidelines, presented as part of the European Society of Cardiology (ESC) annual congress in Munich this week, were developed by a 23 member expert Task Force on Myocardial Revascularization of the European Society of Cardiology. The guidelines provide recommendations for the management of heart attack patients from diagnosis to treatment, and are used by health care teams across Europe.
bivalirudin was recognized by the expert panel as having both the highest strength of recommendation and level of evidence from clinical research (Class I, level of evidence B) of any intravenous antithrombotic listed in the updated guidelines.
Efthymios Deliargyris, MD, Global Medical Director for The Medicines Company, commented, "Over the last years, great strides have been made in the management of STEMI. Compared to a few years ago, thanks to advances in treatment techniques, technologies and medicines available for use in patients with STEMI, the risk of dying has been markedly reduced."
Cees Heiman, Senior Vice President and Regional Engagement Leader for Europe and the Middle East for The Medicines Company said, "Since the last guideline update in 2010, several milestones regarding Angiox and The Medicines Company in Europe have occurred. Most notably, in June 2011, The Lancet published the final three year results of a clinical trial called HORIZONS-AMI that was conducted globally in 3,602 STEMI patients undergoing primary PCI. We welcome these latest updates to the guidelines, as they will help health care teams make informed decisions in providing the best care for their patients."
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-ST segment elevation MI planned for urgent or early intervention. Please see full prescribing information available at http://www.angiox.com.
About Angiomax® (bivalirudin) for Injection
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and a 25 minute half-life.
In the United States, Angiomax with provisional GPI is indicated in patients undergoing angioplasty, also called PCI, and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is 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 ACS patients not undergoing PCI or PTCA. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. 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 is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company (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.
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," "plans" 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 the extent of the commercial success of Angiomax, the Company's ability to develop its global operations and penetrate foreign markets, risks associated with the establishment of global operations, whether physicians, patients and other key decision-makers will accept clinical trial results, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, including for additional patient populations, whether the Company will be able to obtain regulatory approvals, 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, 2012, 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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