Ligand Pharmaceuticals (LGND) Says Glaxo (GSK) Submits Regulatory Apps for Promacta/Revolade
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Ligand Pharmaceuticals (Nasdaq: LGND) partner GlaxoSmithKline plc (NYSE: GSK) has submitted regulatory applications in the United States and European Union related to eltrombopag (Promacta/Revolade) and its use to increase platelet counts in patients with chronic hepatitis C virus infection and low platelets (thrombocytopenia), specifically:
- A supplemental New Drug Application to the US Food and Drug Administration for Promacta (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and to optimize interferon-based therapy.
- A variation to the Marketing Authorization Application to the European Medicines Agency for Revolade (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and during interferon-based therapy.
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