The Medicines Company Receives Renewed Authorization to Market Bivalirudin in Europe

July 7, 2014—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 (bivalirudin) following a review of the latest clinical, safety, and efficacy data, as well as the Angiox risk management plan. The Committee for Medicinal Products for Human Use recommendation for the renewal of the marketing authorization for Angiox reconfirms its favorable risk-benefit profile, stated the company. In the United States, The Medicines Company markets bivalirudin as Angiomax.

As noted by the company, 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.

According to The Medicines Company, the renewal is applicable to Angiox in all member states of the European Union/European Economic Area. Angiox has a favorable class IB recommendation for use in STEMI and NSTEMI patients undergoing primary PCI in the European Society of Cardiology guidelines, which inform clinical decision making.

In Europe, Angiox is currently 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 UA/NSTEMI planned for urgent or early intervention.

In the United States, Angiomax is indicated in patients undergoing PCI with provisional use of glycoprotein IIb/IIIa inhibitor and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes not undergoing PCI or percutaneous transluminal coronary angioplasty, stated The Medicines Company.

The company advised that bivalirudin has been shown to provide comparable efficacy and reduced bleeding compared to heparin with or without glycoprotein IIb/IIIa inhibitor use in patients undergoing PCI in more than 20 years of clinical study. Bivalirudin has been studied in 13 multicenter 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 3 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.