The FDA has granted Promacta (eltrombopag tablets; GlaxoSmithKline) full approval for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) in patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta initially received FDA orphan drug designation in May 2008 and accelerated approval in November 2008 for chronic ITP.

The labeling for Promacta has been updated to include changes to the initial dose regimen, dose adjustments, and to the Warnings and Precautions section (eg, thrombotic/thromboembolic complications, hepatotoxicity risk, bone marrow reticulin formation). The labeling also now includes efficacy and safety data from RAISE, a 6-month, randomized, double-blind, placebo-controlled study in patients with ITP which showed that patients treated with Promacta were significantly more likely to achieve a platelet count between 50,000/μL and 400,000/μL during the entire 6-month treatment period compared to those treated with placebo. The updated labeling also incorporates two-year safety data from an open-label, single-arm extension study in patients with chronic ITP, which showed that adverse reactions occurred in a pattern similar to those reported in the placebo-controlled studies.

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