FDA approves GSK's PROMACTA to treat rare blood disorder

GlaxoSmithKline (NYSE: GSK) today announced that the United States Food and Drug Administration (FDA) granted full approval for PROMACTA® (eltrombopag), an oral tablet that can raise platelet counts in patients with the rare blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

PROMACTA initially received FDA orphan drug designation in May 2008 and accelerated approval in November 2008 for chronic ITP.  The FDA Accelerated Approval program offers a pathway to gain provisional marketing approval for therapies that address unmet patient needs.  Full approval of the therapy requires completion of post-marketing clinical trials and commitments that verify clinical benefit.

"Full approval of PROMACTA was based on clinical studies that provide physicians and patients with a broader understanding of its treatment effect and safety profile," said Steven Stein, MD, V.P. of Medicines Development, GlaxoSmithKline.  "PROMACTA is a testament to how the FDA Accelerated Approval Program supports development of therapies that meet unmet patient needs. Patients with limited treatment options gained access to PROMACTA while GSK conducted clinical studies that yielded additional efficacy and safety data."