This article was originally published in Pharmaceutical Approvals Monthly
Vicuron (formerly Versicor) submits NDA for anidulafungin for the treatment of esophageal candidiasis, the firm announces April 28. The NDA also contains data on invasive candidemia/candidiasis and aspergillosis (1Pharmaceutical Approvals Monthly April 1, In Brief). The antifungal is the third filing in the echinocandin class, following Merck's approved Cancidas (caspofungin) and Fujisawa's "approvable" micafungi
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Vicuron’s revised regulatory strategy for anidulafungin involves filing a separate NDA for treatment of invasive candidiasis/candidemia and addressing other concerns through labeling discussions.
FDA’s request for additional bioavailability data on Vicuron’s anidulafungin has extended the user fee goal date to May 25.
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