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Novartis given approval by FDA to market Apligraf for the treatment of venous leg ulcers

Novartis Pharmaceuticals Corp., East Hanover, NJ, has received approval from the U.S. Food and Drug Administration (FDA) to market Apligraf (graftskin) for the treatment of venous leg ulcers. Apligraf is the only living, bilayered skin construct approved for marketing in the U.S. Venous ulcers affect an estimated 600,000 to one million people in the U.S. The efficacy of Apligraf was evaluated in a study involving 14 centers and 240 patients. When applied to ulcers that had lasted more than one year, Apligraf achieved complete wound healing in more than twice as many patients a compression therapy, Novartis reports. The company says Apligraf resulted in more infection that the patients on compression therapy (29.6% vs. 14%). However, the incidence of wound closure was higher in Apligraf-treated patients. Apligraf, which is manufactured in commercial quantities by Organogenesis in Canton, MA, is also being investigated for the treatment of diabetic foot ulcers, pressure sores, dermatological surgery wounds and burns. Contact: Geoffrey Cook - (973) 781-5486
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Publication:Transplant News
Article Type:Article
Geographic Code:1USA
Date:Jun 15, 1998
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