Ligand Announces Approval For Revolade(R) In Europe

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Mar 2010 - 4:00 PDT

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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.

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.

About Eltrombopag

Eltrombopag was given accelerated approval by the U.S. Food and Drug Administration (FDA) under the trade name Promacta® in November 2008, for the treatment of chronic ITP in adults who have had an insufficient response to corticosteroids, immunoglobulins or surgical removal of the spleen. Eltrombopag is also approved under the trade name Revolade in Venezuela, Kuwait, Chile and Russia. Eltrombopag was discovered as a result of a research collaboration between GSK and Ligand Pharmaceuticals, and developed by GSK.

Revolade® and Promacta® are registered trade marks of the GlaxoSmithKline group of companies.

Source
Ligand Pharmaceuticals

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