FDA Panel Backs Chiron's Regranex For Diabetic Ulcers

The US Food and Drug Administration's Dermatological and OphthalmicDrugs Advisory Committee has voted 11-4 that Chiron Corp's Regranex (becaplermin gel 0.01%) is safe and effective in the treatment of diabetic ulcers which occur on the lower limbs and feet.

Committee members were not specifically asked to recommend approval of the product, but were asked to vote only on its safety and efficacy. While they supported the drug on these issues, the panel members did say that they wanted some instructions included which would give patients or caregivers an indication about how much to use.

Becaplermin, the active ingredient in Regranex, is a genetically-engineered form of platelet-derived growth factor, a naturally-occurring protein which has been known to stimulate wound-healing for some years. Regranex is the only single-agent topical growth factor to be used clinically to date in this indication, according to the company, although others, including epidermal growth factor and fibroblast growth factors, have been shown to play a role in wound healing.