The FDA found an experimental drug safe and effective for the treatment of diabetic ulcers that occur on the lower limbs and feet.
If given market clearance by the FDA, the gel will be sold by a Johnson & Johnson subsiduary (Chiron) under the brand name Regranex.
Subjects who used it once daily significantly increased their rate of complete healing by 43 percent when compared to a placebo gel. Regranex Gel was safe and well tolerated in clinical trials. It also significantly decreased the time of complete healing by 32 percent.
Chiron expects the FDA to make a decision about market clearance by the end of this year.