Medicine Companys Angiox receives CE Mark for ACS
The European Commission has authorized an expanded use for the Medicines Company’s Angiox (bivalirudin) in adult patients with acute coronary syndromes (ACS).
Angiox received indication specifically for patients with unstable angina or non-ST segment elevation myocardial infarction planned for urgent or early intervention, when used with aspirin and clopidogrel.
The approval is based on results from the ACUITY trial of 13,819 patients with ACS, according to the Parsippany, N.J.-based Medicines Company. 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, plus a GPI.
Angiox monotherapy was associated with 47% less major bleeding compared to standard therapy, the Medicines Company said. Of the patients enrolled in ACUITY, 35% were treated at European hospitals.
The FDA is currently reviewing a supplemental new drug application (sNDA) for Angiomax in ACS, for which the company anticipates FDA action by mid-2008.
Angiox received indication specifically for patients with unstable angina or non-ST segment elevation myocardial infarction planned for urgent or early intervention, when used with aspirin and clopidogrel.
The approval is based on results from the ACUITY trial of 13,819 patients with ACS, according to the Parsippany, N.J.-based Medicines Company. 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, plus a GPI.
Angiox monotherapy was associated with 47% less major bleeding compared to standard therapy, the Medicines Company said. Of the patients enrolled in ACUITY, 35% were treated at European hospitals.
The FDA is currently reviewing a supplemental new drug application (sNDA) for Angiomax in ACS, for which the company anticipates FDA action by mid-2008.