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Old Sat Nov 8, 2008, 05:28 AM
Birgitta-A Birgitta-A is offline
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Join Date: Oct 2007
Location: Stockholm, Sweden
Posts: 1,918
Nplate (AMG 531) not OK for MDS patients

Hi Trudy,
We have been waiting since July 2008 for FDA approval of GlaxoSmithKline´s drug for thrombocytopenia called Eltrombopag/Promacta/Revolade. The last info from FDA was that they should decide 19 Sept 2008 but then they have said that they have too much work to be able to keep the dead lines .

Eltrombopag has been effective in decreasing leukemia cells in tubes but is not in any trials for MDS only for low platelets in Immune Thrombopenic Purpura, hepatitis C (due to treatment with chemo) and other cancers like sarcoma.

I was hoping that we should be able to get Eltrombopag on license in Sweden as soon as it was approved by FDA. Now I have understood that they will be very careful when they give all kinds of growth factors off record because there have been so much problems with drugs for anemia like Aranesp.

There are many drugs for thrombocytopenia in trials. We will know more about them when the abstracts from the hematology conferens called ASH 2008 will be available .

We have no drugs for thrombocytopenia i EU.
Kind regards
Birgitta-A
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