Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced that GlaxoSmithKline (NYSE: GSK) was granted marketing authorization from the European Commission (EC) for Revolade® (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). Eltrombopag is indicated for adult chronic ITP splenectomized patients who have not responded (are refractory) to other treatments, such as corticosteroids and immunoglobulins. Eltrombopag may also be considered as second-line treatment for adult non-splenectomized patients where surgery is contraindicated.
“The marketing authorization from the EC of Revolade highlights Ligand’s success in entering pharmaceutical relationships that ultimately result in market approval. Revolade represents a significant treatment option available for ITP patients and the European approval expands the commercial potential for the drug”
Revolade was submitted for approval in Europe in December 2008, and received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in December 2009. European Commission has granted orphan designation for eltrombopag for the treatment of ITP. Eltrombopag is the first oral platelet generator that stimulates the proliferation and differentiation of megakaryoctes, resulting in an increase in platelet counts. Megakaryocytes are the bone marrow cells that give rise to blood platelets.
“The marketing authorization from the EC of Revolade highlights Ligand’s success in entering pharmaceutical relationships that ultimately result in market approval. Revolade represents a significant treatment option available for ITP patients and the European approval expands the commercial potential for the drug,” said John L. Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals.
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