S-P's antifungal Noxafil gets FDA OK

US drugmaker Schering-Plough says that the Food and Drug Administration has approved its oral antifungal Noxafil (posaconazole) for the prophylactic treatment of invasive Aspergillus and Candida infections. The agency's approval covers use of the drug in the treatment of immuno-suppressed patients aged 13 years and over.

S-P said that the approval is based on the results of two head-to-head studies which compared Noxafil with oral suspensions of the standard azole-based therapies, fluconazole and itraconazole. The results showed that Noxafil conferred a greater reduction in treatment failure than the comparator therapies (27% versus 42%), as well as lowering the rate of all-cause mortality, which was 14% in the drug-treated group, compared with 21% in the cohort that received the standard treatment.

In addition, the trials demonstrated that Noxafil reduced the occurrence of both proven and probable invasive fungal infections to a greater extent than either of the other drugs (2% vs 8%), specifically lowering the level of Aspergillosis to 1%, compared with its 7% occurrence in the patient group randomized to received the standard therapy.