Schering-Plough Noxafil "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schering-Plough plans to respond to FDA's request for additional data "as soon as possible" following the agency's June 10 "approvable" letter for the oral triazole antifungal Noxafil (posaconazole). Noxafil's user fee date for treatment of refractory invasive fungal infections fell in March, but Schering previously said the agency extended the review timeframe for an undisclosed length of time. The firm had been projecting a first-half 2005 decision...
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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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