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FDA Approves Pfizer Antifungal Medicine Vfend (Voriconazole)

New drug expands options for treatment of life-threatening fungal infections

NEW YORK, NY -- May 28, 2002 -- Pfizer Inc said today that the U.S. Food and Drug Administration has given marketing clearance for both oral and intravenous formulations of Vfend® (voriconazole) for the treatment of deadly fungal infections.

Vfend is indicated for primary treatment of acute invasive aspergillosis and salvage therapy for rare but serious fungal infections caused by the pathogens Scedosporium apiospermum and Fusarium spp. In the largest clinical trial of its kind, Vfend demonstrated superior efficacy and a survival benefit versus the current treatment standard, amphotericin B, for primary treatment of invasive aspergillosis, a deadly fungal infection occurring in immunecompromised patients.

The number of patients at risk for serious fungal infections is growing as more patients undergo bone marrow and solid organ transplants as well as aggressive chemotherapy for cancer. Fungal infections in these immunosuppressed patients are associated with high morbidity and mortality and require prompt and effective treatment.

Vfend was discovered by Pfizer researchers in Sandwich, England and was developed to address the unmet medical need for more effective and better-tolerated options for patients with invasive aspergillosis and other serious fungal infections.

Results from the largest prospective comparative clinical trial in invasive aspergillosis ever conducted showed that 53 percent of patients who received Vfend had a successful response at 12 weeks of treatment, compared to 32 percent of those who received amphotericin B. The survival rate of the Vfend-treated patients was 71 percent versus 58 percent of those in the amphotericin B arm of the study.

Vfend can be administered both orally and intravenously, unlike most current available treatments. This allows for flexibility in patient care with Vfend, permitting step-down therapy, an important consideration when treating invasive fungal infections. The most common side effects reported among Vfend patients were visual disturbances, elevations of liver function tests and skin rash. These were generally mild to moderate in severity and usually did not result in discontinuation of treatment.

Pfizer said Vfend will be available in hospitals this summer.

Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best-known consumer products.

Full prescribing information is available upon request, or at http://www.pfizer.com.

SOURCE: Pfizer Inc

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