TMC Angiomax sNDA: Is Study With GP IIb/IIIa Enough To REPLACE Heparin?
This article was originally published in Pharmaceutical Approvals Monthly
The Medicines Company intends to file an sNDA in the first half of 2003 to update labeling for its thrombin inhibitor Angiomax with data on use with glycoprotein IIb/IIIa inhibitors from the REPLACE-2 study.
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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)...
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