Anidulafungin was superior to Diflucan (fluconazole) in the primary endpoint – global response at the end of intravenous therapy. Anidulafungin also demonstrated 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.
“We believe these exciting results demonstrating the superiority of anidulafungin will enable us to present anidulafungin, if approved by the FDA, as an important new option to battle invasive infections due to Candida,” said George Horner, III, president and CEO of Vicuron.
The company is on track to file a new drug application (NDA) with the FDA for this indication in Q3 2005, and aims to complete the submission of an amendment to the esophageal candidiasis NDA in Q2 2005.