EC clears Angiox for ACS with UA or NSTEMI

The Medicines Company, a New Jersey, USA-based developer of products for acute hospital care, says that the European Commission has approved an expanded indication for its drug Angiox (bivalirudin). Specifically, the EC has cleared use of the product, in combination with aspirin and clopidogrel, in adult patients suffering acute coronary syndromes with either unstable angina or non-ST-segment elevation myocardial infarction.

TMC explained that the approval is based on the results of the ACUITY trial in which the drug, with or without a glycoprotein IIb/IIa inhibitor, achieved similar rates of ischemic clinical outcomes to the standard heparin/GPI regimen. The firm added that Angiox as a monotherapy was associated with a 47% reduction in major bleeding events compared with heparin/GPI.

On the other side of the Atlantic, the Food and Drugs Administration is currently reviewing a supplemental New Drug Application for the agent in the USA, where it is sold as Angiomax, in ACS, and is expected to issue a decision before the third quarter of the year.