Pfizer's antifungal medicine VFEND® receives FDA approval

12/28/04

NEW YORK, December 28, 2004 – Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) approved the use of its extended-spectrum antifungal VFEND® (voriconazole; IV for injection, tablets, and oral suspension) for the treatment of candidemia in nonneutropenic patients (those without low white blood cell counts) and the following Candida infections: disseminated (deep tissue) infections in skin and infections in abdomen, kidney, bladder wall, and wounds. Bloodstream infections caused by Candida (candidemia) are the fourth most common type of hospital-acquired bloodstream infections in the Unites States and have the highest mortality rate.

According to the U.S. Centers for Disease Control and Prevention, candidemia occurs in eight of every 100,000 persons per year. Those at risk for disseminated Candida infections include patients with compromised immune systems such as stem-cell and organ-transplant recipients, surgical patients, and critically ill patients in the intensive care unit.

"This new approval is important because there is now clinical proof of VFEND's first-line systemic efficacy against a broad range of serious fungal infections," said Dr. Ann Kolokathis, Vice President US Medical at Pfizer. "VFEND is effective against clinically relevant Candida species including hard-to-treat pathogens, such as C glabrata and C krusei, which cause these life threatening infections. In addition, VFEND is available in IV and oral formulations, offering dosing convenience for patients and potentially resulting in cost savings and shorter hospital stays."

The basis for the approval of VFEND to treat candidemia in nonneutropenic patients was a randomized, open-label, comparative, multi-center study involving 422 patients worldwide. Patients were randomized two-to-one to receive either VFEND (n = 283) or amphotericin B followed by fluconazole (n = 139). A data review committee, comprised of fungal disease experts, assessed clinical response at the end of therapy and two, six and 12 weeks after end of therapy. Success in the primary endpoint was defined as cured or improved at the 12-week assessment. In the study, VFEND was shown to be as effective as a regimen of amphotericin B followed by fluconazole. Treatment with VFEND was able to clear Candida from the blood as quickly as amphotericin B with lower incidence of treatment-related adverse events. The most common adverse events in the study were sepsis, fever, hypokalemia, hypotension and respiratory disorder.

Source: Eurekalert & others

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