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February 14, 2005
Vicuron Pharmaceuticals reported positive results of a phase III trial of anidulafungin, for the treatment of hospital acquired candidiasis/candidemia. Study data exceeded their primary endpoint of non-inferiority, establishing statistically superior global response in the intent-to-treat population vs. standard therapy with fluconazole at the end of treatment (75.6%, n=96/127 vs. 60.2%, n=71/118; p<0.05). Secondary endpoints were also met, with superiority established in global response at 2 week follow-up (64.6%, n=82/127, vs. 49.2%, n=58/118), and non-inferiority established in global response at 6 week follow-up (55.9%, n=71/127, vs. 44.1%, n=52/118). This randomized, double-blind, multi-center study enrolled 256 subjects with invasive candidiasis/candidemia, who received daily doses of either 100 mg anidulafungin or 400 mg fluconazole for 10-42 days. Based on these results, the company announced plans to amend their pending NDA for esophageal candidiasis in Q2 2005, and file an NDA for the drug for invasive candidiasis/candidemia in Q3 2005.