FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T97-64                         Lenore Gelb:         301-827-6242
Dec 17, 1997                   
                               Consumer Inquiries:  800-532-4440

NEW BIOTECH PRODUCT FOR DIABETIC ULCERS

FDA has approved the first biotechnology product to treat deep diabetic foot and leg ulcers. This product, becaplermin, is produced through recombinant DNA technology and when combined with standard care, can improve the likelihood of complete healing.

About 16 million people in the United States have diabetes and approximately 15 percent develop chronic ulcers of the foot and leg. Patients with diabetic ulcers are at higher risk for local and systemic infections and amputation.

A majority of diabetic ulcers are quite deep and also have an adequate blood supply. Becaplermin is approved to treat these ulcers, but is not currently indicated for other ulcers, such as those caused by pressure.

Becaplermin must be used as a topical treatment, along with the surgical removal of infected and dead tissue, daily cleanings, the strict avoidance of weight-bearing activities and other standard measures for ulcer management.

The active ingredient in becaplermin is platelet derived growth factor (PDGF). This growth factor, normally found in the blood, is produced in the lab by inserting a gene into yeast. It works by recruiting and promoting cell growth that helps to heal the ulcer.

Clinical studies of the product indicate that the likelihood of complete ulcer closure, after up to 20 weeks of treatment, is greater when becaplermin is used. Typical problems associated with ulcers were not increased, although 2 percent of the patients using becaplermin or the placebo gel had rashes.

The efficacy of becaplermin for non-diabetic ulcers is currently being evaluated by its sponsor, R.W. Johnson Pharmaceutical Research Institute, Raritan, N.J. It will be marketed under the trade name Regranex Gel by Ortho-McNeil Pharmaceutical, Raritan, N.J.

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