The approval is based on results from the Acuity trial of 13,819 patients with acute coronary syndromes (ACS). Acuity has 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.
John Kelley, president and COO of The Medicines Company, said: “With the European Commission decision, the benefits of Angiox can now be extended to the ACS patient populationl.”