The priority review designation means FDA is expected to make a decision on the NDA for the investigational compound within six months of the submission. If approved, Promacta (eltrombopag) would be the first oral thrombopoeitin receptor agonist for the short-term treatment of previously treated patients with chronic ITP to increase platelet counts and reduce bleeding. Promacta is an investigational, once-daily oral treatment that induces the production of cells in the bone marrow to generate platelets, which are critical in minimizing the incidence of bleeding in chronic ITP.
GSK also plans to submit a marketing authorization application for eltrombopag in the treatment of chronic ITP in Europe in 2008 where it will be marketed as Revolade. The compound is also being studied for long-term treatment of chronic ITP, as well as thrombocytopenia associated with hepatitis C virus cirrhosis and chemotherapy induced thrombocytopenia.
Paolo Paoletti, senior vice president of the Oncology Medicine Development Center at GSK, said: “Our goal for Promacta is to make available a targeted therapy in oral form for patients to help raise their platelet counts without having to suppress the immune system.”