GlaxoSmithKline Files for FDA Approval of PROMACTA(TM) (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Bloo...( Application Data Show PROMACTA Si...),Health

Application Data Show PROMACTA Significantly Raised Platelet Counts and Lowered Bleeding Risk in Clinical Trials for the Short-Term Treatment of Patients with Chronic Idiopathic Thrombocytopenic Purpura (ITP)

PHILADELPHIA and LONDON, Dec. 20 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK; London) today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for approval to market PROMACTA(TM) (eltrombopag). If approved, eltrombopag would be the first oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding. Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding.(1,2) Eltrombopag is an investigational, once-daily oral treatment that induces the proliferation and differentiation of cells in the bone marrow to produce platelets.

"Patients with chronic ITP do not have a treatment option that offers the convenience of an oral platelet growth factor," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "GSK is pleased with the data provided to support the NDA and hopeful that, if approved, PROMACTA may provide physicians and chronic ITP patients with a new, convenient and effective option for treating this difficult disease."

GSK also plans to submit a Marketing Authorization Application (MAA) for eltrombopag in Europe in 2008.

About the Data Submitted

The NDA submission is supported by the largest database of clinical trial
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