FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorders

Last update: 5:43 p.m. EST Nov. 20, 2008
PHILADELPHIA, Nov 20, 2008 /PRNewswire-FirstCall via COMTEX/ -- GlaxoSmithKline (GSK:

GSK 32.54, -2.51, -7.2%) today announced that the United States Food and Drug Administration (FDA) granted accelerated approval for PROMACTA(R) (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The approval is a significant milestone for PROMACTA and the ITP community, as PROMACTA is the first oral thrombopoietin (TPO) receptor agonist approved for adult patients with chronic ITP. GSK expects PROMACTA to be available by the next week.
"It is very important for chronic ITP patients to have new treatment options to manage the symptoms of this serious and, at times, life-threatening disease. In addition, many people with chronic ITP are concerned about everyday activities for fear of an accidental bump or unanticipated bruise that may lead to bleeding," said Craig Conway, executive director of the Platelet Disorder Support Association. "The approval of this new product represents a promising new treatment option that offers hope to the ITP community."