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FDA Approves Pfizer Antifungal Medicine Vfend(R) (voriconazole)

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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

compromised 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


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