Angiomax supplement "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Data from additional clinical studies will likely be needed for approval of The Medicines Company's Angiomax (bivalirudin) sNDA for patients with thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome undergoing percutaneous coronary intervention. FDA deemed the supplement "not approvable" because of "deficiencies in the study methods used and in the analysis of the clinical data," the firm says June 3. "We had anticipated a label change in 2004, but this timeframe now seems unlikely," CEO Dave Stack said. The sNDA also includes the REPLACE-2 study of bivalirudin use in combination with glycoprotein IIb/IIIa inhibitors (1Pharmaceutical Approvals Monthly Dec. 1, 2002, p. 6)...
Data from additional clinical studies will likely be needed for approval of The Medicines Company's Angiomax (bivalirudin) sNDA for patients with thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome undergoing percutaneous coronary intervention. FDA deemed the supplement "not approvable" because of "deficiencies in the study methods used and in the analysis of the clinical data," the firm says June 3. "We had anticipated a label change in 2004, but this timeframe now seems unlikely," CEO Dave Stack said. The sNDA also includes the REPLACE-2 study of bivalirudin use in combination with glycoprotein IIb/IIIa inhibitors (1 Pharmaceutical Approvals Monthly Dec. 1, 2002, p. 6).... |