Antifungal Medicine VFEND(reg) Gets FDA Approval for Serious Bloodstream Infections

Main Category: Blood / Hematology
Also Included In: Immune System / Vaccines
Article Date: 29 Dec 2004 - 12:00 PDT

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Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) approved the use of its extended-spectrum antifungal VFEND(reg) (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.

About VFEND

VFEND was discovered by Pfizer researchers and was developed to address the unmet medical need for more effective and better-tolerated options for patients with serious fungal infections.

VFEND is currently approved in the United States for the treatment of invasive aspergillosis, esophageal candidiasis and as salvage therapy for fungal infections caused by pathogens Scedosporium apiospermum and Fusarium species.

Since its introduction, VFEND has proven to be an important treatment option for patients with serious and potentially life-threatening fungal infections. VFEND received U.S. approval in 2002 for the first-line treatment of invasive aspergillosis and as salvage therapy for fungal infections caused by the pathogens Scedosporium apiospermum and Fusarium species. In 2003, VFEND received an additional U.S. indication for use in treating esophageal candidiasis. VFEND comes in IV and oral formulations, allowing patients to remain on the same medication throughout the course of treatment, both on an inpatient and outpatient basis.

The most frequently reported adverse events in all VFEND clinical trials were visual disturbances, fever, rash, vomiting, nausea, diarrhea and headache. The treatment-related adverse events that most often led to discontinuation were elevated liver function tests, rash and visual disturbances.

www.vfend.com

VFEND(reg) Full U.S. Prescribing Information (PDF)

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