Vicuron Pharmaceuticals Inc. announced that it has received notification from the US Food & Drug Administration (FDA) that the agency now anticipates completing its review of the anidulafungin New Drug Application (NDA) on May 25 2004, which represents a 90-day extension of the original action date. The company continues to expect the launch of anidulafungin, its novel hospital anti-fungal agent, in the first half of 2004 as planned.
The extension was triggered by the agency's request for additional pharmacokinetic data. According to PDUFA (Prescription Drug User Fee Act), the FDA can reset the action date to review any additional data.
"We are working closely with the FDA to complete their review, which we expect will be within the revised timeframe," said Timothy Henkel, Vicuron's chief medical officer. "We have been in close contact with the agency throughout the process, and it is our understanding that this extension is not related to any specific concerns regarding safety and efficacy and should therefore not impact our ability to launch anidulafungin according to plan."
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 per cent 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.