Monday May 8, 4:42 pm Eastern Time
FDA panel backs product for diabetic foot ulcers
GAITHERSBURG, Md., May 8 (Reuters) - Federal advisers on Monday backed a product made using human skin cells for helping to heal diabetic foot ulcers, wounds that are hard to treat and that can lead to amputations.
The product, known as Apligraf, is manufactured by Canton, Mass.-based Organogenesis Inc. (AMEX:ORG - news). Novartis AG holds marketing rights to Apligraf, which has been sold in the U.S. market since 1998 for treating leg ulcers caused by circulatory problems.
Now, the companies are asking the Food and Drug Administration to allow promotion of Apligraf for diabetic foot ulcers, which afflict between 600,000 and 800,000 U.S. diabetics each year. The FDA usually follows its panels' advice. |
