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[IP] Fw: FYI : drug for diabetic foot ulcers




-----Original Message-----
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.
>Ignace

               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
               amputation. 

               "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
               alone.

               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
               Pharmaceutical, Inc.