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GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP
Date:12/6/2008

PHILADELPHIA, Dec. 6 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced positive safety and efficacy results from RAISE (RAndomized placebo- controlled ITP Study with Eltrombopag), a Phase III study of PROMACTA(R) (eltrombopag) in adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who had received one or more prior ITP therapies. Patients receiving PROMACTA were eight times more likely than those on placebo to maintain platelet counts between 50,000 to 400,000/microliters during a six- month treatment period, thereby reducing patients' bleeding symptoms and their need for concomitant and rescue ITP treatments. These data were presented at the 50th Annual Meeting of the American Society of Hematology (ASH), December 6-9, 2008, in San Francisco, CA.

"PROMACTA is the first approved agent to show that generating platelets can be achieved and maintained with an oral therapy," said Paolo Paoletti, M.D., Senior Vice President of Oncology R&D, GSK. "With the continued emergence of GSK in oncology, we want patients and physicians to continuously benefit from our dedication to developing truly innovative treatments that can help improve patients' lives. PROMACTA is a great example of this commitment."

PROMACTA received accelerated approval from the FDA on November 20 as a thrombopoietin receptor treatment for patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. PROMACTA should not be used in an attempt to normalize platelet counts.

Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of b
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SOURCE GlaxoSmithKline
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