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  4. [verwijderd] 4 december 2007 12:49

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  13. [verwijderd] 4 december 2007 13:10

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    Wow
    COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS PUBLIC SUMMARY OF POSITIVE OPINION FOR ORPHAN DESIGNATION OF recombinant human C1-inhibitor for the prevention of delayed graft function in organ transplant On 20 February 2007, orphan designation (EU/3/07/435) was granted by the European Commission to Pharming Group N.V., Netherlands, for recombinant human C1-inhibitor for the prevention of delayed graft function in organ transplant. What is delayed graft function in organ transplant? Delayed graft function occurs when, in the immediate stage after transplantation, the organ or the tissue transplanted from a donor to recipient does not start functioning properly. The cause of delayed graft function may be related to events occurring after the restoration of blood flow to a transplanted organ, which takes place after the temporary interruption of blood supply between removal of the organ from the donor and its placement in the receiving patient. This damage, called “reperfusion injury”, is associated with an inflammatory reaction, characterised by an invasion of white blood cell in the transplanted organ, and activation of a group of proteins called the complement system. Delayed graft function is life-threatening, due to the risk of graft loss. What are the methods of prevention available? At the time of submission of application for orphan drug designation, there was no method authorised in the European Union for the prevention of delayed graft function after solid organ transplant. The preventive measures to reduce delayed graft function in organ transplant consist of donor management and organ preservation solutions. What is the estimated number of patients at risk of developing the condition*? According to the information provided by the sponsor, the number of patients undergoing solid organ transplantation each year was considered to be about 23,000 persons in the European Union. How is this medicinal product expected to act? Recombinant human C1-inhibitor is analogous to a natural human protein, C1-inhibitor, which circulates in low levels in the blood. C1-inhibitor works by blocking the activation of the complement system; complement activation is thought to play a critical role in the reperfusion injury. Blocking complement activation is known to improve the function of transplanted kidneys in experimental models. What is the stage of development of this medicinal product? At the time of submission of the application for orphan designation, no clinical trials with recombinant human C1-inhibitor in patients with delayed graft function in organ transplant were initiated.
  15. [verwijderd] 4 december 2007 13:11

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    European Medicines Agency
    Pre-authorisation Evaluation of Medicines for Human Use
    7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
    Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 40
    E-mail: orphandrugs@emea.europa.eu www.emea.europa.eu
    ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged Document Date: London, 30 November 2007 Doc.Ref.: EMEA/COMP/13308/2007 COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS PUBLIC SUMMARY OF POSITIVE OPINION FOR ORPHAN DESIGNATION OF recombinant human C1-inhibitor for the prevention of delayed graft function in organ transplant
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