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Saturday, 1st January 2005
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Bloodstream infections caused by Candida have the highest mortality rate
among hospital-acquired bloodstream infections in the Unites States.
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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.
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.
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