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Mar 15, 2010

GSK Wins EC Clearance for Drug to Treat Idiopathic Thrombocytopenic Purpura

  • GlaxoSmithKline (GSK) was granted marketing authorization from the European Commission (EC) for Revolade® as a treatment of thrombocytopenia in adults with chronic immune thrombocytopenic purpura (ITP). It is indicated for adult chronic ITP splenectomized patients who have not responded to other treatments such as corticosteroids and immunoglobulins. Eltrombopag may also be considered as second-line treatment for adult nonsplenectomized patients where surgery is contraindicated, the company notes.

    Revolade has orphan designation for ITP from the EC. It is reportedly the first oral platelet generator that stimulates the proliferation and differentiation of megakaryoctes, resulting in an increase in platelet counts. The drug was discovered as a result of a research collaboration between GSK and Ligand Pharmaceuticals and developed by GSK.

    Revolade was given accelerated approval by the FDA under the trade name Promacta® in November 2008 for the treatment of chronic ITP in adults who have had an insufficient response to corticosteroids, immunoglobulins, or surgical removal of the spleen.


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