Angiomax gains new indication
Executive Summary
FDA approved The Medicines Company's Angiomax (bivalirudin) for use in percutaneous coronary intervention with "provisional use" of glycoprotein IIb/IIIa inhibitors (GPIs) June 13. The new indication was based on the REPLACE-2 study of 6,002 patients undergoing PCI, with 12.7% of Angiomax patients with certain risk factors qualifying for provisional use of GPIs (62.2% of these patients actually used a GPI). FDA had previously found the REPLACE-2 supplement "not approvable" in June 2004 due to deficiencies in both the study methods and the analysis (1"The Pink Sheet" June 7, 2004, In Brief)...
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