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news.Biotech company Pharming Group has received notice from the European Medicines Evaluation Agency that orphan drug designation has been granted to Rhucin for prevention of delayed graft function after organ transplantation.
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Pharming believes that although the number of transplantations is currently relatively small, DGF is an important medical need providing a significant market opportunity. Transplantation procedures are costly and patients often have to wait a long time before transplantation can be performed. Reduction of the frequency of DGF will, therefore, provide a valuable medical and economical benefit.
In delayed graft function (DGF), the transplanted organ or tissue does not function properly after transplantation. This may be caused by an immune response of the recipient or by damage caused by oxygen or other external factors during the transplantation procedure.
Current treatments include the use of immune suppressing agents. Pharming's product Rhucin works in a different way than the current treatments and may, therefore, provide additional benefits.
Pharming has provided evidence to the EMEA which makes it plausible that Rhucin will have a beneficial effect in preventing the occurrence of DGF. First clinical studies in humans, to be started after completion of animal studies, will focus on determining the right dose in humans and aiming at demonstrating a significant positive effect in preventing DGF.