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PH WEDNESDAY PART 1

585 Posts
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  13. [verwijderd] 5 december 2007 09:09

    • [verwijderd]

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    dit emea doc vertalen? zijn verdorie maar een paar zinnen, rest kan zo copy/paste >>als ze het nog ergens bewaard hebben op een pc bij Ph!
    DuccieDuc
  14. banditos33 5 december 2007 09:10

    • banditos33

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    Wel ongelofelijk dat er weinig animo is terwijl er toch wat leuks in een paar dagen gaat komen, lijkt wel of ze allemaal zitten te wachten op het startschot:-)
  16. [verwijderd] 5 december 2007 09:10

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    Wat staat hier nou? Is nu al zo vaak gebeurd hier

    COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
    PUBLIC SUMMARY OF
    POSITIVE OPINION FOR ORPHAN DESIGNATION

    Designation toewijzing van de weesgeneesmiddelen status. niet goedkeuring van het product nog.
       ~
  18. [verwijderd] 5 december 2007 09:10

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    blijf raar vinden dat nu de heren analisten niet aan de deur kloppen bij strijker. Of hij zelf even met een opmerking in betten komt of gewoon mooi een officieel pb. Zo'n grote moeite is dat niet.
  19. [verwijderd] 5 december 2007 09:10

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    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

    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.
    * Disclaimer: For the purpose of the designation, the number of patients affected by the condition is estimated and assessed based on data from the European Union (EU 25), Norway, Iceland and Lichtenstein. This represents a population of 459,700,000 (Eurostat 2004). This estimate is based on available information and calculations presented by the sponsor at the time of the application.
    ©EMEA 2007
    Page 2/3
    Recombinant human C1-inhibitor was not authorised anywhere worldwide for prevention of delayed graft function in organ transplant, at the time of submission. Orphan designation of recombinant human C1-inhibitor was granted in the United States for the condition in June 2006.
    According to Regulation (EC) No 141/2000 of 16 December 1999, the Committee for Orphan Medicinal Products (COMP) adopted on 10 January 2007 a positive opinion recommending the grant of the above-mentioned designation.
    __________________________
    Opinions on orphan medicinal products designations are based on the following cumulative criteria: (i) the seriousness of the condition, (ii) the existence or not of alternative methods of diagnosis, prevention or treatment and (iii) either the rarity of the condition (considered to affect not more than five in ten thousand persons in the Community) or the insufficient return of development investments.
    Designated orphan medicinal products are still investigational products which were considered for designation on the basis of potential activity. An orphan designation is not a marketing authorisation. As a consequence, demonstration of the quality, safety and efficacy will be necessary before this product can be granted a marketing authorisation.


    http://www.emea.europa.eu/pdfs/human/comp/opinion/1330807en.pdf
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