First Approval Of Regranex Gel For Foot Ulcers

Johnson & Johnson's platelet-derived growth factor product Regranex Gel(bepaclermin 0.01%) has been approved in the USA for the treatment of diabetic foot ulcers. The product is scheduled for launch in February 1998, and will be marketed by J&J's Ortho-McNeil Pharmaceutical subsidiary. It was developed by another J&J subsidiary, the RW Johnson Pharmaceutical Research Institute, in collaboration with Chiron.

Specifically, Regranex is indicated for treating lower-extremity neuropathic ulcers that extend into the subcutaneous tissue or beyond, but which have an adequate blood supply. It is intended for use as an adjunct to traditional ulcer care strategies, such as initial sharp debridement (removal of dead tissue), daily dressing changes, pressure relief and treatment of infection if present.

Data from a 382-patient pivotal study has demonstrated that Regranex, applied once-daily in combination with good wound care, increased the incidence of complete healing by 45% compared to a placebo gel. Regranex also significantly decreased the time to complete healing by 32%, equivalent to six weeks. The incidence of adverse events, including infection and cellulitis, was similar in patients treated with Regranex, placebo, or good wound care alone.