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FDA Approves Eltrombopag for the Treatment of Chronic Immune Thrombocytopenic Purpura
NEW YORK -- November 21, 2008 -- The US Food and Drug Administration (FDA) has approved eltrombopag (Promacta) for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
"Preventing platelet destruction has always been the primary means of treating patients with ITP. Recent advances, like the clinical trials of eltrombopag, show that increasing the production of platelets may also play a significant role in treating this disorder," said James Bussel, MD, Platelet Disorders Center, Children's Cancer and Blood Foundation Division of New York Presbyterian/Weill Cornell Medical Center, New York, New York. "The entire ITP community, including physicians, patients, and their families may benefit from this shift in thinking and these innovative new treatments."
The indication is based on data from 2 pivotal studies in the short-term treatment and 1 ongoing long-term treatment study of patients with chronic ITP.
Eltrombopag may cause hepatotoxicity. Patients receiving therapy with eltrombopag must have regular monitoring of serum liver tests. Treatment should be discontinued if alanine aminotransferase levels increase to ³3X upper limit of normal and are progressive; or persistent for more than 4 weeks; or accompanied by increased direct bilirubin; or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
Reinitiating treatment is not recommended and should be considered only with close medical supervision and under exceptional circumstances where the potential benefit outweighs the risk.
Because of the risk for hepatotoxicity and other risks, eltrombopag is available only through a restricted distribution program in which only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive eltrombopag.
SOURCE: GlaxoSmithKline
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