GSK’s Promacta slated for committee review

Executive Summary

GlaxoSmithKline's idiopathic thrombocytopenic purpura therapy Promacta will undergo a review by FDA's Oncologic Drugs Advisory Committee May 30. GSK is seeking approval for short-term, second-line use of Promacta (eltrombopag) to increase platelet counts and reduce or prevent bleeding in patients with chronic ITP. The company plans to follow up with a broader application for chronic ITP this year. Amgen's platelet producer Nplate (romiplostim) recently received ODAC support, but a major amendment has since delayed the application (1"The Pink Sheet," March 17, 2008, p. 3)...