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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

marrow to produce platelets.(6,7)

"These long-term results on safety and efficacy are encouraging and suggest that PROMACTA, once approved, may provide physicians with a new treatment option to raise and maintain patients' platelet levels and alleviate their ITP symptoms," said James B. Bussel, MD, director of the Platelet Disorders Center, Children's Blood Foundation Division at New York-Presbyterian Hospital/Weill Cornell Medical Center, and principal investigator for this trial.

The EXTEND study

EXTEND is a study designed to assess the long-term safety and efficacy of PROMACTA as an oral treatment for increasing platelets in patients with chronic ITP. EXTEND is an open-label study for patients who had participated in previous PROMACTA trials and were eligible to receive PROMACTA.(8)

Study design(8)

Chronic ITP patients were administered a starting dose of 50 mg/day (which can be increased to 75 mg/day at any time after 3 weeks) in order 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 (stage 1). Then, concomitant ITP medications, if taken at study entry, were tapered to a minimal dose or discontinued entirely (stage 2), whilst maintaining a platelet count of greater than or equal to 50,000/microliters. PROMACTA was then titrated to a minimal effective dose (25-75 mg/day) required to maintain platelet counts of 50,000/microliters-200,000/microliters (stage 3). PROMACTA is continued for as long as patients continue to benefit and platelets remain greater than or equal to 50,000/microliters (stage 4). Bleeding incidences and severity were assessed using the WHO bleeding scale (Grade 0-4).

Study results(1)

At the time of this analysis PROMACTA had been administered to 94 patients. Evaluable subjects (n=89) had a median treatment duration of 151 days, with the longest treatment duration a
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SOURCE GlaxoSmithKline
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