GSK receives European CHMP positive opinion for Revolade

Dec 18 2009

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its partner GlaxoSmithKline (NYSE: GSK) has received a positive opinion for Revolade® (eltrombopag/Promacta®) from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).

The CHMP has recommended the marketing authorization of eltrombopag in the European Union for the treatment of ITP in adult patients who have had their spleen removed, and who do not respond to other treatments, such as corticosteroids and immunoglobulins therapies. Eltrombopag may also be considered as a second-line treatment for adult patients where surgery to remove their spleen is contraindicated.

“Approval in Europe presents an expanded market opportunity for eltrombopag and is an exciting development for Ligand as it continues to validate Ligand’s success in contributing to the discovery of novel and important commercial therapies,” said John L. Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. “Eltrombopag enjoys in excess of 10 years remaining patent life in both the U.S. and Europe, and the European approval of Revolade expands the commercial potential for the drug. We commend GSK for their clinical and regulatory successes and commitment to developing eltrombopag for other indications.”

ITP patients experience bruising and bleeding and, in some cases, serious hemorrhages, which can be fatal. ITP may also affect a patient’s quality of life, as it is often associated with fatigue and depression and a fear of bleeding may limit everyday activities. Traditional treatments with corticosteroids, immunoglobulins or splenectomy (removal of the spleen) all have potential drawbacks for chronic treatment of ITP patients.