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GlaxoSmithKline Files for FDA Approval of PROMACTA(TM) (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder
Date:12/20/2007

ous bleeding was observed in fewer eltrombopag patients (16%) than placebo patients (36%). The most common adverse event (AE) observed in this study was headache, reported in 8% and 11% of patients receiving eltrombopag and placebo respectively. Other common AEs occurring in at least 5% of eltrombopag subjects included nausea, nasopharyngitis, diarrhea and vomiting.

About the Phase II Data(4)

The Phase II study was a multicenter, randomized, double-blind, placebo-controlled trial examining once daily oral dosing of eltrombopag. One hundred and eighteen adults with chronic ITP and platelet counts less than 30,000/microliter who had relapsed or were refractory to at least one ITP treatment were randomized to eltrombopag (30mg, 50mg, or 75 mg), or placebo. The primary endpoint was the proportion of patients with a platelet count greater than or equal to 50,000/microliter after up to six weeks of dosing.

After six weeks of treatment in chronic ITP patients, eltrombopag at daily doses of 30mg, 50mg and 75mg elevated platelet counts to greater than or equal to 50,000/microliter in 28% (8/29), 70% (19/27) and 81% (21/26) of patients respectively compared to 11% (3/27) of patients receiving placebo (pless than0.001). After seven days of treatment 44% and 62% of patients receiving eltrombopag 50mg and 75mg, respectively, achieved a platelet count of greater than or equal to 50,000/microliter. After 15 days, 88% and 81% of patients receiving eltrombopag 50mg and 75mg respectively had responded, with the median platelet counts approaching the normal range (i.e., 150-400,000/microliter). Platelet counts rose to greater than 200,000/microliter in 4% (1/27) of placebo-treated patients and in 14% (4/29), 37% (10/27) and 50% (13/26) of eltrombopag 30mg, 50mg and 75mg-treated patients respectively.

Eltrombopag was generally well tolerated in this study. The most common AE, mild-to-moderate headache, was observed at similar rates in both the eltrombo
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SOURCE GlaxoSmithKline
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