Thread: Cladribine?
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06-22-2011, 08:13 PM #1
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Cladribine?
Anyone see anything about Cladribine? I read something that Merck is stopping trying to get FDA approval?
CrazyCatLady
MS Does Not Define Me.....My Love of Tea Does! LOL!
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06-22-2011, 11:37 PM #2
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Yes, it's true. The FDA and European regulators both rejected Merck's drug application for cladribine because of inadequate safety data. The company decided that the additional testing the FDA is asking for would be too costly to pursue. So unless and until Merck reconsiders or another company wants to pick it up, cladribine won't be getting approval for MS. (That doesn't stop doctors from using it off label but, considering the risks involved, not many may choose to.) I think this article sums it up well: [url]http://www.fiercebiotech.com/story/fdas-safety-concerns-force-merck-kgaa-kill-cladribine-ms-program/2011-06-22[/url]
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