New antifungal approved

Abstract

Noxafil oral suspension, a new antifungal agent from Schering-Plough Corp., received marketing approval for the prevention of invasive Aspergillus and Candida infections in patients with severely compromised immune systems, FDA and the company announced September 18. A Schering-Plough spokesman estimated that the product, which contains the novel triazole drug posaconazole, would be available by early October. According to the product’s FDA-approved labeling, posaconazole is indicated for use in patients 13 years or older who are at high risk for developing invasive Aspergillus and Candida infections. These include hematopoietic stem-cell transplant recipients with graft-versus-host disease and patients with neutropenia caused by chemotherapy for hematologic cancer. Schering-Plough stated that posaconazole is the only antifungal drug with FDA-approved labeling for the prevention of invasive Aspergillus infection. Noxafil’s approval was based on the drug’s use as prophylaxis in clinical trials of patients with acute myelogenous leukemia, myelodysplastic syndrome, or graft-versus-host disease secondary to allogeneic stem-cell transplantation.