SCHERING-PLOUGH'S NOXAFIL APPROVED FOR ORAL FUNGAL INFECTION

Schering-Plough announced that the FDA has approved Noxafil (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole. OPC is a fungal infection of the mouth and throat caused by the yeast Candida. Noxafil is a novel triazole antifungal agent discovered and developed by Schering-Plough Research Institute.

This approval follows the FDA approval Sept. 15 of Noxafi for prophylaxis (prevention) of invasive Aspergillus and Candida infections in patients 13 and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Invasive fungal infections are a leading cause of death in these high-risk populations.

In the European Union, the Committee for Medicinal Products for Human Use of the European Medicines Agency on Sept. 21 issued a positive opinion recommending approval of Noxafil for the prophylaxis indication and for first-line treatment of OPC. These applications are currently pending a final European Commission decision. NOXAFIL is currently approved in the EU and Australia for the treatment of certain invasive fungal infections in adult patients with disease that is refractory to or in patients who are intolerant of certain commonly used antifungal agents.

This new FDA approval is based primarily on the results of a randomized, controlled, evaluator-blinded clinical study in HIV-infected patients that compared Noxafil with fluconazole, as well as a non-comparative study of Noxafil in HIV-infected patients with OPC that was refractory to treatment with fluconazole or itraconazole.