Medicines Co. (MDCO) announced that the Committee for Medicinal Products for Human Use or CHMP has granted a positive opinion applicable to all Member States of the European Union/European Economic Area that will extend the use of Angiox (bivalirudin) to include patients with heart attacks - (so-called ST segment elevation myocardial infarction or STEMI - undergoing emergency heart procedures called primary percutaneous coronary intervention or PCI.
The basis of this approval is 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 - were more likely to survive and had less frequent severe bleeds, the company said.
STEMI is the most severe type of heart attack and carries a substantial risk of death and disability. STEMI involves myocardial injury, indicated by significant abnormalities on electrocardiogram called ST-segment elevations.
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