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www.fdanews.com/articles/68507-anidulafungin-better-than-fluconazole-in-invasive-candidiasis-candidemia

Anidulafungin Better Than Fluconazole in Invasive Candidiasis/Candidemia

February 8, 2005

Vicuron Pharmaceuticals has announced results from its Phase III clinical trial evaluating anidulafungin for the treatment of invasive candidiasis/candidemia, the most common hospital-acquired fungal infection.

The study compared anidulafungin to fluconazole, and was designed to show noninferiority. Anidulafungin was superior to fluconazole in the primary endpoint, global response at the end of intravenous therapy in the microbiological intent-to-treat population. Anidulafungin also demonstrated noninferiority or superiority in all secondary endpoints, including responses at the two-week and six-week follow-up visits after completion of therapy.

Anidulafungin was well-tolerated in the study, with a side-effect profile comparable to fluconazole.