FDAnews
www.fdanews.com/articles/102713-gsk-submits-nda-for-blood-disorder-treatment

GSK Submits NDA for Blood Disorder Treatment

January 2, 2008

GlaxoSmithKline (GSK) has filed a new drug application (NDA) with the FDA for Promacta, a potential treatment for chronic idiopathic thrombocytopenic purpura (ITP).

ITP is a rare disorder marked by increased platelet destruction and inadequate platelet production in the blood.

If approved, Promacta (eltrombopag) would be the first oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic ITP to increase platelet counts and reduce or prevent bleeding.

The company said it plans to submit a European application for the drug in 2008.