Ligand (LGND), Glaxo (GSK) Receive FDA Approval for PROMACTA in HCV Patients
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Ligand Pharmaceuticals (Nasdaq: LGND) partner GlaxoSmithKline (NYSE: GSK) announced 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:
* PROMACTA should not be used in an attempt to normalize platelet counts;
* PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy; and
* Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.
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There are limitations to the use of PROMACTA in patients suffering from chronic hepatitis C-associated thrombocytopenia. These include:
* PROMACTA should not be used in an attempt to normalize platelet counts;
* PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy; and
* Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.
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