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GSK Discusses Data From EXTEND Study

December 12, 2007

GlaxoSmithKline (GSK) presented data on the long-term safety and efficacy of its investigational drug Promacta for the treatment of chronic idiopathic thrombocytopenic purpura (ITP), a disorder characterized by low levels of platelets in the blood.

EXTEND is assessing the long-term safety and efficacy of Promacta (eltrombopag) as an oral treatment for increasing platelet counts. Subjects received a starting dose of 50 mg/day to reach a platelet count of greater than or equal to 50,000/microliters or greater than or equal to 100,000/microliters if patients were receiving concomitant ITP medication. 

Promacta was titrated to a minimal effective dose required to maintain platelet counts of 50,000 to 200,000/microliter. Treatment with the drug will continue as long as platelet counts remain greater than or equal to 50,000/micoliter.

Promacta had been administered to 94 patients, 17 of whom had entered Stage 2 of the study. Twenty-seven patients proceeded to the maintenance stage with the drug, achieving median platelet counts of 104,000/microliter, according to GSK.