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FDA approves Novartis' Apligraf for treatment of diabetic foot ulcers.

Novartis Pharmaceuticals Corporation, East Hanover, NJ, announced that the US Food and Drug Administration (FDA) has approved Apligraf for use with conventional diabetic foot ulcer care in the treatment of diabetic foot ulcers (DFU) of greater than 3 weeks duration. Apligraf was developed and is manufactured by Organogenesis, Inc., Canton, MA. Novartis owns exclusive worldwide marketing and distribution rights to the product.

The approval expands the use of Apligraf, which received marketing clearance in 1998 for use in the treatment of venous leg ulcers of greater than 1-month duration that have not adequately responded to conventional therapy alone. The companies say Apligraf is a bi-layered living skin substitute and is the only product of its kind approved for marketing in the US.

In a prospective, randomized pivotal trial, the use of Apligraf with standard care healed 56% of diabetic ulcers within 12 weeks, compared to 39% for standard care alone, Novartis and Organogenesis report. The product also healed the ulcers faster. The median time to closure was 65 days among wounds treated with Apligraf, compared with 90 days for wounds using standard care alone. The patients included in the trial had their ulcers at least 2 weeks prior to entering the study and failed to make good healing progress during the 1 week screening phase.

Contact: Geoffrey Cook, Novartis - (973) 781-5486, or Carol Hausner, Organogenesis - (781) 575-0775
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Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Jun 30, 2000
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