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news.GlaxoSmithKline (GSK) has received the US Food and Drug Administration's (FDA) full approval for its treatment of rare blood disorder, Promacta (eltrombopag).
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GSK said the oral tablet Promacta 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.
Earlier in May 2008 FDA has granted orphan drug status to Promacta and accelerated approval in November 2008 for chronic ITP.
GSK Medicines Development VP Steven Stein said 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.
"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," Stein said.