Eraxis
Generic name: anidulafungin
Treatment for: Candidemia
Vicuron Pharmaceuticals Files New Drug Application (NDA) for Anidulafungin for Treatment of Invasive Candidiasis/Candidemia
KING OF PRUSSIA, Pa., August 18, 2005 -- Vicuron Pharmaceuticals Inc. announced today it filed a New Drug Application (NDA) with the U.S. Food and Drug Administration 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 3 trial demonstrating superiority of anidulafungin versus fluconazole in invasive candidiasis/candidemia.
"We are pleased to have filed this NDA in the third quarter as planned," said George F. Horner, III, Vicuron's President and Chief Executive Officer.
About Anidulafungin
Anidulafungin is a product candidate 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 (e.g., amphotericin B) without the resistance problems found with the azole class (e.g., fluconazole). 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. Preclinical studies have shown that five-minute exposure to anidulafungin in vitro kills more than 99 percent of Candida, including fluconazole-resistant strains. Anidulafungin has not shown cross-resistance with azoles or amphotericin, and in the laboratory it has proven very difficult to develop resistance to anidulafungin.
Posted: August 2005
Related articles
- Eraxis - Pfizer Inc - Treatment for Candidemia - February 17, 2006
- Vicuron Pharmaceuticals Files Amendment to Anidulafungin New Drug Application (NDA) for Treatment of Esophageal Candidiasis - May 31, 2005
- Vicuron Pharmaceuticals Provides Update on Anidulafungin Regulatory Paths - September 21, 2004
- Vicuron Pharmaceuticals Receives Approvable Letter from FDA for Anidulafungin for the Treatment of Esophageal Candidiasis Requesting Additional Data - May 24, 2004
- Vicuron Pharmaceuticals Announces 90-Day Extension of FDA Review of Anidulafungin New Drug Application - January 22, 2004
Eraxis (anidulafungin) FDA Approval History
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