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ICAAC In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Noxafil graft vs. host data: Schering-Plough plans to submit an NDA for use of its novel triazole antifungal Noxafil (posaconazole) for prevention of invasive fungal infections (IFIs) in high-risk patients, the company says. One of the pivotals, presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C. Dec. 16-19, shows significantly greater efficacy in preventing aspergillosis compared to fluconazole. In the 600-patient trial of stem cell transplant recipients with graft-versus-host disease, seven Noxafil-treated patients (2%) developed aspergillosis compared to 21 for fluconazole (7%) (p=0.006). The study poster notes that Noxafil was "as effective" as fluconazole in preventing IFIs other than aspergillosis. A total of 16 Noxafil patients (5%) developed IFI of any kind compared to 27 in the fluconazole group (9%) (p=0.07). Noxafil has been "approvable" since June for refractory invasive fungal infections (1Pharmaceutical Approvals Monthly July 2005, In Brief)...
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