The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: R.W. Johnson
Approval Status: Approved December 1997
Treatment for: diabetic foot ulcers
General Information
REGRANEX (becaplermin) Gel .01% has been approved for the treatment of diabetic foot ulcers that extend into the subcutaneous tissue or beyond, and have an adequate blood supply. This new topical gel, which contains genetically engineered platelet-derived growth factor, is the first prescription biologic that actively stimulates the body to grow new tissue to heal these wounds.
Clinical Results
Clinical trials demonstrated that a once daily topical application of REGRANEX Gel plus good ulcer care healed more diabetic ulcers than placebo gel plus good ulcer care.
Side Effects
REGRANEX Gel was well tolerated in all clinical trials. Incidence of adverse events was similar in patients treated with REGRANEX, placebo gel, or good ulcer care alone.
Mechanism of Action
The active ingredient in REGRANEX Gel is becaplermin, a genetically engineered platelet-derived growth factor that mimics a protein that occurs naturally in the body. The growth factor stimulates the migration of cells to the ulcer site, encouraging the patient's body to grow new tissue that heals these open wounds.
