FDA approves Promacta
GlaxoSmithKline said the FDA has 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 way to gain marketing approval for therapies that address unmet patient needs. Full approval requires completion of post-marketing clinical trials and commitments that verify clinical benefit.