EraxisTreatment for Candidemia
Vicuron 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.
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.
Posted: May 2005
- 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 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