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

PHILADELPHIA, Nov. 20 /PRNewswire-FirstCall/ --GlaxoSmithKline (NYSE: GSK) 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."

Shift in Approach

"Preventing platelet destruction has always been the primary means of treating patients with ITP. Recent advances, like the clinical trials of PROMACTA, show that increasing the production of platelets may also play a significant role in treating this disorder," said James Bussel, M.D., director of the Platelet Disorders Center, Children's Cancer and Blood Foundation Division of New York Presbyterian/Weill Cornell Medical Center. "The entire ITP community, including physicians, patients and their families, may benefit from this shift in thinking and these innovative new treatments."