Public Release: 

Pfizer's VFEND(R) receives FDA approval for treatment of esophageal candidiasis

Edelman Public Relations

NEW YORK, November 17, 2003 -- Pfizer Inc said today that it has received U.S. Food and Drug Administration (FDA) approval to market VFEND® (voriconazole), a broad spectrum antifungal medicine, for the treatment of esophageal candidiasis.

Candida organisms are normally found on skin and mucous membranes in healthy individuals, but in persons whose immune systems are weakened or compromised by cancer chemotherapy, organ transplants or HIV/AIDS, Candida can multiply causing potentially serious infections. In immunocompromised patients, esophageal candidiasis may coat much of the surface of the mouth resulting in pain and difficulty swallowing and may ultimately progress to more serious, invasive disease.

The basis for the approval of VFEND to treat esophageal candidiasis infections was a clinical trial with immunocompromised patients conducted at study sites in 15 countries. All patients had a proven diagnosis of esophageal candidiasis and most of the patients also had additional underlying diseases, such as hematologic malignancies, chronic obstructive pulmonary disease (COPD) and AIDS.

Patients received either VFEND or fluconazole. Those treated with VFEND had success rates of 98 percent compared to 95 percent for fluconazole. Both VFEND and fluconazole had acceptable tolerability and safety. 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 invasive aspergillosis and other serious fungal infections.

Initially, VFEND was approved in the U.S. for the primary treatment of acute invasive aspergillosis and salvage therapy for rare but serious fungal infections caused by the pathogens Scedosporium apiospermum and Fusarium spp. VFEND can be administered both orally and intravenously. Pfizer is continuing to study VFEND for the treatment of serious fungal infections.

In clinical trials, the most common adverse events (all causalities) were visual disturbances, fever, rash, vomiting, nausea, diarrhea, headache, sepsis, peripheral edema, abdominal pain and respiratory disorders. The treatment-related adverse events that most often led to discontinuation in clinical trials were elevated liver function tests, rash and visual disturbances.

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Full prescribing information available upon request or at www.pfizer.com or www.vfend.com.

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