To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: European Commission Approves Vfend (Voriconazole) For Treatment Of Life-Threatening Fungal Infections URL: http://www.pslgroup.com/dg/214F42.htm Doctor's Guide March 21, 2002
NEW YORK, NY -- March 21, 2002 -- Pfizer Inc said today that the European Commission has authorized marketing of both oral and intravenous formulations of Vfend® (voriconazole) for the treatment of potentially fatal fungal infections. The Commission approved Vfend primarily for treatment in immuno-compromised patients with progressive, possibly life-threatening infections that include acute invasive aspergillosis; fluconazole-resistant serious invasive Candida, (including C. krusei); and serious fungal infections caused by Scedosporium spp. and Fusarium spp. Fungal infections in immunosuppressed patients are associated with high morbidity and mortality and require prompt and aggressive treatment. At greatest risk for these infections are patients whose immune systems are severely compromised by cancer chemotherapy, bone marrow or organ transplantation, high-dose corticosteroid use and AIDS. "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 more aggressive chemotherapy," said Dr. Joseph Feczko, Pfizer's Senior Vice President for Medical and Regulatory Operations. "Among invasive aspergillosis patients treated with currently available medicines, the mortality rate is greater than 50 percent. So there is a great unmet medical need for more effective treatment options." Pfizer researchers at the company's laboratories in Sandwich, England, discovered voriconazole in the 1980s to address the high mortality rates in patients with severe fungal infections. Previously available treatments may only be active against a limited number of fungal infections or may cause serious toxicity, and some of these medicines are not available in both oral and intravenous formulations. Studied in more than 2,000 patients worldwide, Vfend has a broad-spectrum of anti-fungal activity and can be administered both orally and intravenously. This allows for flexibility in patient care and the possibility of prolonged treatment, both of which are important in treating invasive fungal infections. Clinical data showed that 53 percent of patients who received Vfend had a successful outcome after 12 weeks of treatment, compared to 32 percent of those assigned to receive amphotericin B, the standard treatment. The survival rate of the Vfend-treated patients was 71 percent versus 58 percent of those in the amphotericin B arm of the study. 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 become available in hospitals throughout Europe over the coming months. SOURCE Pfizer Inc --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.