EU gives nod to Medicines Companys Angiomax

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Bivalirudin (Angiomax; Medicines Company), an anticoagulant used in STEMI patients who undergo PCI, has been approved by the European Commission.

According to the Parsippany, N.J.-based company, bivalirudin is a direct thrombin inhibitor with a reversible mechanism of action and a 25-minute half-life that should be administered with aspirin and clopidogrel.

The approval was based on the HORIZONS-AMI study that analyzed 3,602 patients presenting symptoms of STEMI, undergoing an emergency PCI who were administered either bivalirudin or heparin with glycoprotein IIb/IIIa inhibitors (GPI).

After a 30-day follow-up, results showed that patients taking bivalirudin fared better than those taking heparin plus GPI. Those administered bivalirudin had a 38 percent decrease in mortality, 42 percent decrease in major bleeding incidents, 26 percent decrease in adverse clinical events and showed comparable rates of major adverse cardiac events.

The drug is available in all 27 European member states and its indication is planned for January, according to the company.