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[IP] Fw: FYI : drug for diabetic foot ulcers
From: Ignace HINDRICK <email @ redacted>
To: Diabetes-List <email @ redacted>
Date: Sunday, December 21, 1997 5:56 AM
Subject: FYI : drug for diabetic foot ulcers
>I am not marketing a product, just want to inform you about
>the FDA approval.
Regranex Gel Approved In U.S. For Diabetic Foot Ulcers
RARITAN, NJ -- December 17, 1997 -- The United States Food and Drug
Administration (FDA) has granted marketing clearance for Regranex(R)
(becaplermin) Gel 0.01%, the first biologic proven to increase the incidence of
complete healing in diabetic foot ulcers.
When used as an adjunct to good ulcer care, Regranex Gel is indicated for the
treatment of lower extremity diabetic neuropathic ulcers that extend into the
subcutaneous tissue or beyond and have an adequate blood supply. Diabetic
foot ulcers are one of the most difficult types of wounds to heal. 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. Good ulcer care practices, including initial sharp debridement
(removal of dead tissue), daily dressing changes, pressure relief and treatment of
infection if present, are required to achieve the best results with Regranex Gel.
The product will be available in early 1998.
More than two million people with diabetes will develop foot ulcers during their
lifetime. Foot ulcers often go undetected since other ailments associated with
diabetes -- such as nerve damage and visual and circulatory problems -- make it
difficult for patients to feel or see the ulcer as it develops. These open sores often
don't heal and may lead to serious complications including severe infection and
"Diabetic foot ulcers are a serious problem in this country, resulting in 67,000
amputations each year," said Mayer Davidson, M.D., president of the American
Diabetes Association. "Diabetic foot disease costs the nation more than $1
billion each year."
"Wound healing is a complex process that, until now, only Mother Nature could
influence," said David Steed, M.D., professor of surgery, University of
Pittsburgh, and a clinical trial investigator. "Now, with Regranex Gel, we have
something that no drug has ever offered before, a simple, easy-to-use treatment
that actually stimulates the body to heal more diabetic ulcers."
Regranex Gel was well tolerated in all clinical trials. Incidence of adverse events
was similar in patients treated with Regranex Gel, placebo gel or good ulcer care
The active ingredient in the product 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. Becaplermin is produced by recombinant technology
in yeast cells and is not derived from blood.
Regranex Gel was developed by the R.W. Johnson Pharmaceutical Research
Institute and will be marketed in the United States by Ortho-McNeil