GSK receives FDA approval for PROMACTA to treat thrombocytopenia

Published on November 19, 2012 at 11:42 PM · No Comments

GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved PROMACTA for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.  PROMACTA is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts.  PROMACTA in combination with interferon-based therapy has been shown to improve a patient's chance of achieving a sustained virologic response (SVR) or viral cure.

There are limitations to the use of PROMACTA in patients suffering from chronic hepatitis C-associated thrombocytopenia.  These include:

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