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Approvable Letter From FDA Requests Additional Data for Anidulafungin, Treatment of Esophageal Candidiasis
KING OF PRUSSIA, Penn., May 24 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA). However, the letter indicated that the company's NDA submission for anidulafungin does not currently support a labeling claim for the initial treatment of esophageal candidiasis.
In the letter, the FDA indicated that Vicuron could potentially achieve approval for anidulafungin upon the completion of Vicuron's ongoing Phase III clinical trial for the treatment of invasive candidiasis/candidemia or the completion of further clinical work in patients with candidal disease refractory to other treatments.
"We intend to meet with the FDA to discuss all of our options with respect to the approval of anidulafungin as soon as possible, and intend to complete the Phase III trial in invasive candidiasis/candidemia by the end of this year," said George F. Horner III, President and CEO of Vicuron. "We also will take appropriate management action to reduce the expenses of the company in light of this delay."
Anidulafungin is a naturally occurring molecule that has been significantly improved through chemical modification. 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 no 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 I study when given in combination with cyclosporine, a leading chronic immunosuppressive drug.
Source: Vicuron Pharmaceuticals Inc.