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KING OF PRUSSIA, Pa. -- Vicuron Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's anidulafungin New Drug Application (NDA) for review. Anidulafungin belongs to the first new class of anti-fungal agents, called echinocandins, introduced in more than 40 years.
The filing and subsequent acceptance of this NDA follows the successful completion of a pivotal Phase III trial that statistically showed intravenous anidulafungin is as effective as oral fluconazole, the current standard-of-care, in treating esophageal candidiasis. Based on results from this study, anidulafungin is well-tolerated with an adverse event and laboratory safety profile comparable to oral fluconazole. The NDA also includes safety and efficacy data from a large Phase II trial with anidulafungin in invasive candidemia/candidiasis, as well as safety data from a Phase III trial studying anidulafungin in combination with liposomal amphotericin for the treatment of invasive aspergillosis and a number of additional Phase I and Phase II clinical trials.
"With the aging population and a growing number of immuno-compromised patients serious hospital-based fungal infections represent a growing unmet medical need for which more effective treatments are required," said George F. Horner III, president and CEO of Vicuron. "This NDA acceptance brings us one step closer to realizing our goal of bringing vital medicines to the market for these seriously ill patients."
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 candida and aspergillus, fungi responsible for serious systemic infections. Preclinical studies have shown that a 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 the Phase I study when given in combination with cyclosporine, the leading chronic immunosuppressive drug.
Source: Vicuron Pharmaceuticals Inc.