Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Dermatology | Endocrinology | Family Medicine | Podiatry
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REGRANEX (becaplermin) Gel
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: R.W. Johnson
Approval Status: Approved December 1997
Treatment Area: diabetic foot ulcers
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 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.
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