Ligand Partner GSK Receives Marketing Authorization From The European Commission For Additional Revolade™ (Eltrombopag) Indication As The First Approved Treatment For Chronic Hepatitis C-Associated Thrombocytopenia
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner GlaxoSmithKline plc (LSE:GSK) (NYSE:GSK) announced today that the European Commission has granted an additional indication for Revolade™ (eltrombopag) as a treatment for low platelet counts (thrombocytopenia) in adult patients with chronic hepatitis C infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon (IFN)-based therapy. 1
Thrombocytopenia may prevent the initiation 2 and maintenance of peginterferon (pIFN)-based treatment, thereby reducing a patient’s chances of achieving a sustained virologic response (SVR)* 3 - the primary goal of hepatitis C treatment.
“We are extremely pleased with the decision of the European Commission, and eagerly await the launch of Revolade in the European Union for this indication. This is an important achievement, as otherwise very sick patients suffering with chronic hepatitis C infection with few therapeutic options will now have the opportunity to potentially receive needed treatment,” commented John Higgins, President and Chief Executive Officer of Ligand. “Ligand commends GSK’s global Revolade and Promacta team for their commitment to this program and for leading it to continued regulatory success.”
About EltrombopagEltrombopag, marketed under the brand name Revolade™ in Europe and most ex-US countries, and Promacta® in the U.S., is an oral thrombopoietin receptor agonist licensed in over 90 countries around the world as a treatment for thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP). Eltrombopag, indicated in adult patients as a once-daily oral therapy, was approved for chronic hepatitis C-associated thrombocytopenia by the European Commission on September 23, 2013. Promacta®/Revolade™ is approved for chronic hepatitis C associated thrombocytopenia in Argentina, Australia, Bangladesh, Pakistan, Philippines and the US. About GlaxoSmithKline GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances with the world’s leading pharmaceutical companies including GlaxoSmithKline, Onyx Pharmaceuticals, Merck, Pfizer, Baxter International, Bristol-Myers Squibb, Lundbeck Inc., Eli Lilly & Co. and Spectrum Pharmaceuticals. Please visit www.captisol.com for more information on Captisol and www.ligand.com for more information on Ligand. Follow Ligand on Twitter @Ligand_LGND.
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