EC Approves Angiox for Acute Coronary Syndrome Patients
January 29, 2008 - The Medicines Company received the European Commissionï¿½s authorization of an expanded use for Angiox (bivalirudin) in adult patients with acute coronary syndromes (ACS), specifically patients with unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI) planned for urgent or early intervention, when used with aspirin and clopidogrel.
ï¿½With this new indication, Angiox can be used in patients experiencing ACS throughout the treatment paradigm, from arrival in the emergency department to the cardiac catheterization laboratory,ï¿½ said Walter Desmet, MD, PhD, Department of cardiology, University Hospital Gasthuisberg (Leuven, Belgium). ï¿½Angiox is a simple and effective option to meet the needs of ACS patients who require urgent or early.ï¿½
The approval is based on results from the ACUITY trial of 13,819 patients with ACS.1 ACUITY demonstrated that Angiox with or without a glycoprotein IIb/IIIa inhibitor (GPI) resulted in similar rates of ischemic clinical outcomes compared to standard therapy of heparin (unfractionated or enoxaparin) plus a GPI. Importantly, Angiox monotherapy was associated with 47 percent less major bleeding2 compared to standard therapy. Of the patients enrolled in ACUITY, 35 percent were treated at European hospitals.
In the United States, an sNDA for Angiomax in ACS is being reviewed by the FDA. The Company expects FDA action in mid-2008.
For more information: www.angiomax.com