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Long-Term Safety and Efficacy Data on Promacta(TM) (Eltrombopag) Presented at American Society of Hematology Annual Meeting
Date:12/10/2007

Preliminary results demonstrate patients with chronic idiopathic thrombocytopenic purpura increased and maintained platelet counts at greater than or equal to 50,000/microliters with extended treatment

ATLANTA, Dec. 10 /PRNewswire-USNewswire/ -- GlaxoSmithKline today announced data on the long-term safety and efficacy of its investigational drug PROMACTA(TM) (eltrombopag) for the treatment of chronic idiopathic thrombocytopenic purpura (ITP).(1) These preliminary results from the EXTEND (Eltrombopag eXTENded Dosing) study showed that of the patients with a baseline platelet count of less than 30,000/microliters, 73% achieved a platelet count of greater than or equal to 50,000/microliters. The average treatment period for all patients, from this ongoing treatment study, has lasted almost 22 weeks (five months) so far. These results suggest that PROMACTA sustains increased platelet counts during long-term treatment.(1) This research was presented at the 49th Annual Meeting of the American Society of Hematology, December 8-11 2007 in Atlanta, GA.

PROMACTA is an investigational compound that has not received regulatory approval in any market for any indication at this time.

PROMACTA was generally well tolerated in this study. Of the 94 patients who received at least one dose of PROMACTA, 83% reported at least one adverse event (AE), 32% reported a drug-related AE and 13% reported a serious AE (SAE). Most AEs were mild in severity with the most common being headache (20%).(1)

Chronic ITP is a disorder characterized by low levels of platelets in the blood, with patients suffering from excessive bruising and bleeding and in some cases having serious hemorrhages that can be fatal.(2,3,4) An estimated 200,000 individuals are diagnosed with ITP in the U.S.(5) and a similar number in Europe. PROMACTA is an investigational oral, non-peptide, platelet growth factor that induces the proliferation and differentiation of cells in the bone
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SOURCE GlaxoSmithKline
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