Japan's health regulator approves GlaxoSmithKline's Revolade and Xyzal

UK pharmaceutical giant GlaxoSmithKline (LSE: GSK) says that it has received approval in Japan from the Ministry of Health, Labor and Welfare (MHLW) for Revolade (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP), and for Xyzal (levocetirizine dihydrochloride).

Revolade is the world’s first oral treatment that stimulates the production of blood platelets, which are essential to normal clotting, according to GSK. ITP patients experience bruising and bleeding and, in some cases, serious haemorrhages, which can be fatal. I

Eltrombopag was given accelerated approval by the US Food and Drug Administration 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 following surgical removal of the spleen. It was approved for use in Europe in March 2010 under the trade name Revolade as an oral treatment for thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). Eltrombopag was discovered as a result of a research collaboration between GSK and Ligand Pharmaceuticals (Nasdaq: LGND), and developed by GSK.