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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

GLOBAL: FDA Expands Glaxo-Ligand Promacta to Hepatitis C Patients


Reuters (11.19.12)

The US Food and Drug Administration (FDA) has approved the drug Promacta, made by GlaxoSmithKline, Plc, and Ligand Pharmaceuticals, Inc. Promacta will be used to treat low platelet count in hepatitis C patients. The FDA’s approval was based on results from two late-stage studies that collectively enrolled 1,521 patients. Through the use of Promacta, patients will be able to undergo a standard therapy for the liver disease. Promacta has already been approved as a treatment for idiopathic thrombocytopenic purpura, the condition of having a low platelet count of unknown cause. In the United States, approximately 3.2 million people have chronic hepatitis C, which is the most common blood-borne virus, according to the US Centers for Disease Control and Prevention (CDC). The drug, also known as eltrombopag, is approved in 90 countries; it is marketed under the brand name Promacta in the United States and as Revolade elsewhere. Promacta is now the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based hepatitis C therapy due to low platelet counts.


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