FDA Approves Pfizer Antifungal Medicine Vfend(R) (voriconazole)
May 29, 2002
New drug expands options for treatment of life-threatening fungal infections
NEW YORK, May 28 /PRNewswire-FirstCall/ -- Pfizer Inc said today that the
U.S. Food and Drug Administration has given marketing clearance for both oral
and intravenous formulations of Vfend(R) (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 immune
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
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