Eraxis
anidulafungin
Treatment for CandidemiaVicuron Pharmaceuticals Files Amendment to Anidulafungin New Drug Application (NDA) for Treatment of Esophageal Candidiasis
KING OF PRUSSIA, Pa., May 31, 2005 -- Vicuron Pharmaceuticals Inc. announced it filed an amendment to its existing anidulafungin New Drug Application (NDA) with the U.S. Food and Drug Administration for the treatment of esophageal candidiasis. The amendment provides supplemental clinical data including data on the 100 mg dose of anidulafungin from the previously announced Phase 3 trial demonstrating superiority of anidulafungin versus fluconazole in invasive candidiasis/candidemia.
"We are pleased to have filed this NDA amendment in the second quarter as planned, and remain on track to file a new NDA for the treatment of invasive candidiasis/candidemia in the third quarter," 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. Anidulafungin also was well tolerated in a Phase 1
study when given in combination with cyclosporine, a leading
chronic immunosuppressive drug.
About Vicuron Pharmaceuticals
Vicuron Pharmaceuticals is a biopharmaceutical company focused on
discovering, developing, manufacturing and commercializing vital
medicine for seriously ill patients. The company has two New Drug
Applications submitted to the U.S. Food and Drug Administration for
its lead products, dalbavancin, a novel intravenous antibiotic for
the treatment of serious Gram-positive infections, and
anidulafungin, a novel antifungal agent. Vicuron applies a
disciplined, integrated approach to anti-infective discovery for
next- generation compounds in both hospital-based and
community-acquired infections. In addition, the company has
research and development collaborations with leading pharmaceutical
companies, such as Pfizer.
Related Articles:
Eraxis - Pfizer Inc - Treatment for Candidemia - February 17, 2006
Vicuron Pharmaceuticals Files New Drug Application (NDA) for Anidulafungin for Treatment of Invasive Candidiasis/Candidemia - August 18, 2005
Vicuron Pharmaceuticals Provides Update on Anidulafungin Regulatory Paths - September 21, 2004
Vicuron Pharmaceuticals Announces 90-Day Extension of FDA Review of Anidulafungin New Drug Application - January 22, 2004
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