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Elan Corporation, plc Message Board

  • dar200 dar200 Nov 24, 2004 12:41 PM Flag

    Off-label use

    Off-label use will start immediately for CD and, assuming the RA trial results are good, for RA when results are released. I suppose the stupid analysts havn't thought of this yet.

    IMO, by mid 2005 eln/biib will be capacity bound.

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    • You know thats very interesting.I just had a conversation this morning with my wife about this because her office manager has RA and her husband has chroyns and the employers health care provider told her that a new drug due to be approved (antegren) would be covered.I told her I found it hard to believe because it is only approved by the FDA for MS and it would be an "off label" use...but that the RA was in ph 2 and chroyns was in ph 3 and maybe they could get into the trails.I`ll relay more info on this when I find out the particulars.She ,I believe is now taking retuxion for her RA and I`ve forgotten what he takes for his chroyns....

      JR>.

      <Off-label use will start immediately for CD and, assuming the RA trial results are good, for RA when results are released. I suppose the stupid analysts havn't thought of this yet.>

      • 1 Reply to elechdret50
      • Perhaps someone with more FDA expertise than I will help out here.

        It is my layman's understanding that an approved drug for one indication may be prescribed by a doc for any indication. However, the docs are looking over their shoulder at malpractice suits, so are loath to depart from the label, UNLESS, there has been at least one peer-reviewed study showing a benefit for another indication. We already have that with CD and soon will have it with RA.

        It is also my understanding that a drug co can market to docs (not the public) off-label use provided one peer-reviewed study on the second indication has been published. We are already there with CD, which is pending before Europe based on published trial results.

        Any help here on off-label use will be appreciated.

 

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