GlaxoSmithKline gets EU approval for oral platelet generator Revolade; names new chiefs for GSK Biologicals

UK drug giant GlaxoSmithKline as been granted marketing authorization from the European Commission for Revolade (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the rare blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Eltrombopag, developed under a research collaboration with USA-based Ligand Pharmaceuticals, 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) at the end of last year (the Pharma Letter December 21, 2009). The 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.