Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.EU regulatory body CHMP has adopted a positive opinion to extend the indication for The Medicines Company's Angiox to adult patients with acute coronary syndromes planned for urgent or early intervention, specifically patients with unstable angina or non-ST segment elevation myocardial infarction.
Subscribe to our email newsletter
The positive opinion is based on results from the ACUITY trial of 13,819 patients with acute coronary syndromes (ACS), which found 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% less major bleeding compared to standard therapy. Of the patients enrolled in ACUITY, 35% were treated at European hospitals.
John Kelley, president and COO of The Medicines Company, said: “The Committee for Medicinal Products for Human Use (CHMP) recommendation will accelerate our efforts to establish Angiox as the preferred anti-thrombotic strategy for patients who require PCI for coronary artery disease in Europe. We believe the European Commission will approve expanded use of Angiox in ACS patients during the first quarter of 2008, which coincides with the expansion of our commercial operations into major European markets.”