GlaxoSmithKline and partner Ligand Pharmaceuticals are celebrating the news that their blood disorder drug Revolade has gained marketing approval in the European Union.

The European Commission has granted marketing authorisation for Revolade (eltrombopag), an oral drug for the treatment of adults with idiopathic thrombocytopenic purpura who have had their spleen removed. The therapy may also be used as second-line treatment for non-splenectomised patients where surgery is contraindicated.

The approval for Revolade, which has been sold as Promacta in the USA since November 2008 (after being given accelerated approval by the US Food and Drug Administration), was expected after it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2009. GSK and Ligand notes that eltrombopag is the first oral platelet generator that stimulates the proliferation and differentiation of megakaryoctes, the bone marrow cells that give rise to blood platelets.

Revolade will now compete with Amgen's injectable ITP treatment Nplate (romiplostim) which was approved in Europe just over a year ago. Analysts believe that the GSK/Ligand drug could have annual sales in the region of $250 million by 2012.

Changes at GSK Biologicals
GSK has also announced management changes related to its vaccines business as part of “a planned succession strategy”. Jean Stephenne has been appointed chairman of GSK in addition to his role as president of the unit, and over the next two years, operational responsibility will “transition” to GSK’s chairman of R&D, Moncef Slaoui who will continue in the latter role.