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The Medicines Co. receives market authorization renweal for Angiox

The Medicines Company announced that the European Medicines Agency, the Committee for Medicinal Products for Human Use, and the European Commission have granted market authorization renewal for Angiox 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, including patients with ST-segment elevation myocardial infarction undergoing primary PCI. Angiox is also indicated in Europe for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction 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.