The Medicines Company gets EU appro for Angiox for heart attack patients undergoing emergency procedures

New Jersey, USA-based drugmaker The Medicines Company has received European Union approval for the use of Angiox (bivalirudin) as an anticoagulant in patients with heart attacks (so-called ST-segment elevation myocardial infarction; STEMI) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI).

The Commission decision extends the current EU licence for Angiox and is applicable to all EU member states and the European Economic Area, following a positive opinion from the European Medicines Agency (EMEA) advisory body in October.

This approval was based on the landmark HORIZONS-AMI study which was the first drug trial to demonstrate a reduction in deaths from heart attacks in patients undergoing emergency PCI. The trial showed that patients treated with Angiox compared with today's leading treatment - heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) ' were more likely to survive and had less frequent severe bleeds.

Prof Christian Hamm, Director of the Department of Cardiology and Medical Director, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany, commented: 'The HORIZONS trial is the most recent demonstration of the efficacy of bivalirudin and shows a remarkable reduction of mortality in patients with STEMI undergoing primary PCI. The robustness of these findings from this trial is impressive and reflects a landmark in the treatment of these high risk patients in Europe."