The Medicines Company Receives Market Authorization Renewal for Angiox® (Bivalirudin) from the European Medicines Agency and the European Commission
The Medicines Company (NASDAQ:MDCO) today announced that the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP), and the European Commission have granted market authorization renewal for Angiox® (bivalirudin) following a review of the latest clinical, safety, and efficacy data, as well as the Angiox risk management plan. The CHMP recommendation for the renewal of the marketing authorization for Angiox reconfirms its favorable risk-benefit profile.
Angiox is a direct thrombin inhibitor and is indicated in Europe as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. Angiox is also indicated in Europe for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention.
The renewal is applicable to Angiox in all Member States of the European Union/European Economic Area. Angiox has a favorable class 1B recommendation for use in STEMI and NSTEMI patients undergoing primary PCI in the European Society of Cardiology guidelines, which inform clinical decision making.
In more than 20 years of clinical study, bivalirudin has been shown to provide comparable efficacy and reduced bleeding versus heparin with or without glycoprotein IIb/IIIa inhibitor (GPI) use in patients undergoing PCI. Bivalirudin has been studied in thirteen multi-center clinical trials and one-single center randomized clinical trial in more than 35,000 patients, supporting the use of bivalirudin in the PCI setting regardless of femoral or radial access site and type of P2Y12 inhibitor. In STEMI patients, bivalirudin has demonstrated the reduction of mortality out to three years, independent of bleeding status. In addition, large, observational, real-world registries have collected data from approximately 500,000 patients that also support these findings.
”The renewal issued by the EMA and CHMP underscores the clinical value and importance of Angiox in contemporary interventional cardiology,” said Simona Skerjanec, Pharm.D., Senior Vice President and Acute Cardiovascular Care Global Innovation Group Leader at The Medicines Company. “Angiox continues to be a critical antithrombin option for interventional cardiologists globally who rely on it as a part of their therapeutic armamentarium in the cath lab and PCI setting of care. Angiox has been shown to have similar ischemic outcomes and reduced bleeding complications vs. standard of care, as well as reduction in mortality in Horizons AMI. Its benefits are consistent with our mission to save lives, alleviate suffering, and improve the economics of healthcare globally.”
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.
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 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," "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 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 with the SEC on May 12, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Note: This press release was issued in the United States and is intended as reference information for U.S. investors and journalists.
The Medicines Company
Neera Dahiya Ravindran, MD, +1 (973) 290-6044
Vice President, Investor Relations & Strategic Planning