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Versicor preparing anidulafungin NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Versicor says it is on track to file its I.V. anidulafungin NDA by the end of April. Phase III esophageal candidiasis trial shows anidulafungin to be as effective as the standard of care, Pfizer's Diflucan. Anidulafungin yielded endoscopic success in 97.2% (242/249) patients compared to 98.8% (252/255) of patients on oral fluconazole, which "easily met" the statistical requirement for non-inferiority, Versicor says. However, anidulafungin had a statistically significantly higher relapse rate: endoscopic success at two weeks was 89.5% (205/229) for Diflucan and 64.4% (150/233) for anidulafungin. The NDA will also contain data from a Phase II trial in invasive candidemia/candidiasis and interim safety data from an ongoing Phase III study in aspergillosis. Anidulafungin could be the third entrant in the echinocandin class - Merck's Cancidas (caspofungin) was approved Jan. 26, 2001 and Fujisawa's micafungin was deemed "approvable" Jan. 29 (Pharmaceutical Approvals Monthly Feb. 1, In Brief
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