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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

information on investigational therapies for chronic ITP patients. Two pivotal trials, one Phase III trial and one Phase II trial, were submitted to support the NDA submission.

About the Phase III Data(3)

The Phase III study was an international, randomized, double-blind, placebo-controlled trial that enrolled 114 adults with chronic ITP and baseline platelet counts of less than 30,000/microliter. The primary endpoint in this study was a platelet count of greater than or equal to 50,000/microliter after up to six weeks of therapy. An endpoint of 50,000/microliter was selected because at a platelet count of greater than 50,000/microliter patients have a low risk of bleeding and bruising. Eligible patients must have had a platelet count less than 30,000/microliter, had failed or stopped responding to one or more chronic ITP therapies such as corticosteroids, immunoglobulins and/or splenectomy. Patients were allowed to continue on a concomitant chronic ITP medication, provided their dose had been stable for at least a month prior to enrollment. These patients were randomized to either placebo or eltrombopag 50mg (76 patients) once daily for up to six weeks. Patients were assessed for platelet count weekly and for six weeks following discontinuation of treatment with eltrombopag. Bleeding events were assessed weekly using the World Health Organization (WHO) bleeding scale. The study was originally presented by investigator Drew Provan, M.D., Senior Lecturer in Haematology, Department of Haematology, Royal London Hospital, U.K. at the 2007 Congress of the European Hematology Association in Vienna, Austria.

At the end of the trial, 59% of eltrombopag treated patients on the 50mg dose and 16% of placebo treated patients achieved a platelet count of greater than or equal to 50,000/microliter. Importantly, there was a significantly lower incidence of bleeding during treatment with eltrombopag compared to placebo (p=0.029). Clinically significant seri
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