CHMP Recommends Expanded Use of Angiox

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion to extend the indication for The Medicines Company’s Angiox to adult patients with acute coronary syndromes (ACSs).

The positive opinion is based on results from the ACUITY trial of 13,819 patients with ACS, which found that Angiox (bivalirudin), with or without a glycoprotein IIb/IIIa inhibitor (GPI), resulted in similar rates of ischemic clinical outcomes compared with standard therapy of heparin (unfractionated or enoxaparin) plus a GPI, The Medicines Company said.

The company markets bivalirudin as Angiomax in the U.S. A similar ACS filing is being reviewed by the FDA, and the company expects to hear from the agency in mid-2008.