Bioengineered skin clears FDA approval hurdle
Bioengineered skin clears FDA approval hurdle
Dermagraft and Apligraf are endorsed
A Food and Drug Administration (FDA) advisory panel has recommended marketing approval for the bioengineered skin equivalents Dermagraft and Apligraf.
The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee of the FDA recommended approval of Dermagraft (Advanced Tissue Sciences, La Jolla, CA) for the treatment of diabetic foot ulcers, under the condition that the company perform a post-marketing study. The panel also recommended approval for Apligraf (Organogenesis, Canton, MA) for treatment of venous leg ulcers.
Dermagraft is a living, human dermal replacement produced by culturing human dermal fibroblasts onto a bioabsorbable scaffold. Dermagraft is currently available in Canada, the United Kingdom, and several European countries.
"The panel's favorable recommendation represents another major step forward in the commercialization of unique, human-based tissue engineering solutions for the treatment of diabetic foot ulcers," said Gail K. Naughton, PhD, president and chief operating officer of Advanced Tissue Sciences.
The skin equivalent has increased the rate of healing in diabetic foot ulcers and has proven to be a valuable tool for preventing amputation, says Marvin Levin, MD, professor of clinical medicine emeritus and associate director of the Diabetes, Endocrinology and Metabolism Clinic at Washington University School of Medicine in St. Louis. Levin has experience in working with bioengineered skin.
The FDA committee's recommendation came after the company presented clinical trial data demonstrating the safety and efficacy of Dermagraft in reaching its primary endpoint: complete healing of the diabetic foot ulcers within 12 weeks.
Diabetic foot ulcers affect approximately 15% of the 16 million diabetic patients in the United States at some time, according to Advanced Tissue Sciences.
Apligraf, which was approved in Canada in August 1997 for treating venous leg ulcers, consists of both living human epidermal and dermal cells. The company estimates that one million people in the U.S., and four million globally, suffer from venous leg ulcers.
In clinical trials, Apligraf was found to be more effective than compression therapy, which is standard therapy for venous leg ulcers.
Both companies expect final FDA clearance within the next several months. (See the January issue of Wound Care for a detailed discussion on bioengineered skin, and the February issue for a description of the clinical uses of Apligraf.)
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