FDAnews
www.fdanews.com/articles/75728-vicuron-files-application-for-candidiasis-treatment

VICURON FILES APPLICATION FOR CANDIDIASIS TREATMENT

August 24, 2005

Vicuron Pharmaceuticals has filed a new drug application (NDA) with the FDA for anidulafungin for the treatment of invasive candidiasis/candidemia, the most common hospital-acquired fungal infection. The NDA includes clinical data from a previously announced Phase III trial demonstrating superiority of anidulafungin versus fluconazole in invasive candidiasis/candidemia.

Anidulafungin is made through chemical modification of a naturally occurring molecule. In vitro studies have demonstrated that anidulafungin combines both the potency and killing effects of the polyene class without the resistance problems found with the azole class. Anidulafungin is a broad-spectrum agent, and has been demonstrated to be highly potent in vitro against the fungi responsible for several serious fungal infections.