What is Regranex?
Regranex is a medicine that contains the active substance becaplermin.
What is Regranex used for?
Regranex is used in conjunction with other good wound care practices to promote granulation (healing of skin tissues) of long-lasting skin ulcers in diabetes patients. Regranex is used in neuropathic ulcers smaller than or equal to 5 cm2. Neuropathic ulcers are caused by nerve problems and not by a problem of blood supply in the affected area.
The medicine can only be obtained with a prescription.
How is Regranex used?
Treatment with Regranex should be under the supervision of a doctor who has experience in the treatment of diabetic wounds.
The ulcer must be cleaned with water or saline before each application of Regranex. A layer of gel must then be applied to all the ulcerated areas, once a day, using a clean application medium, for example, a padded pad. Later the sites must be covered with a gauze moistened with physiological solution. The dressing must not be air-tight or water-tight.
Regranex should not be used for more than 20 weeks and should always be associated with good ulcer care, which is to keep the wound clean and avoid applying pressure during healing. A Regranex tube should only be used for one patient. Regranex should be used with care to ensure that the gel is not contaminated with bacteria. For further details, see the package leaflet.
The safety and efficacy of Regranex in patients under the age of 18 have not been established.
How does Regranex work?
The active substance in Regranex, becaplermin, is a copy of a human protein called platelet-derived growth factor BB. Growth factors are proteins that stimulate cell multiplication. Human platelet-derived growth factors act on the cells involved in wound repair. Becaplermin is produced by a method known as "recombinant DNA technology": that is, it is produced by a yeast into which a gene (DNA) has been inserted that makes it able to produce the BB growth factor derived from human platelets. Becaplermin acts in the same way as the naturally occurring growth factor by stimulating cell growth and promoting the growth of normal tissue for healing.
What studies have been carried out on Regranex?
Regranex has been studied in one main study and three complementary studies involving diabetic adults who had developed at least one diabetic ulcer for at least eight weeks. Overall, the studies examined 922 ulcers. Regranex was compared with placebo (a dummy treatment) and with no treatment, but all patients received standard wound care. The main measure of effectiveness was the number of ulcers completely healed after 20 weeks.
What benefit has Regranex shown during the studies?
When the results of the four studies were examined together, Regranex had cured approximately 10% more ulcers than the gel as a placebo.
Regranex has cured 47% of ulcers with a surface area of less than 5 cm2, compared to 35% of ulcers treated with the gel as a placebo and 30% of those treated only with standard wound care.
What is the risk associated with Regranex?
The most common side effects of Regranex (seen in over one in 10 patients) are infection, cellulitis (inflammation of the subcutaneous tissues) and ulceration of the skin. For the full list of all side effects reported with Regranex, see the Package Leaflet.
Regranex should not be used in people who may be hypersensitive (allergic) to becaplermin or any of the other substances. It should not be applied on or near skin tumors or on infected ulcers.
Why has Regranex been approved?
The Committee for Medicinal Products for Human Use (CHMP) has decided that Regranex's benefits outweigh the risks associated with other good wound care practices in promoting granulation and, consequently, in healing chronic full-thickness diabetic ulcers and neuropathic in nature and of a size less than or equal to 5 cm2. The Committee recommended that Regranex be given marketing authorization.
More information on Regranex
On 29 March 1999, the European Commission granted a marketing authorization for Regranex, valid throughout the European Union, to Janssen-Cilag International NV. The marketing authorization was renewed on 29 March 2004 and 29 March 2009.
The full EPAR for Regranex can be found here.
Last update of this summary: 03-2009.
