GSK submits sNDA for Promacta in Thrombocytopenia -GSK
GlaxoSmithKline reported the submission of a supplemental New Drug Application (sNDA) to the FDA for Promacta (eltrombopag), seeking an additional indication in pediatric patients six years old and older with chronic immune (idiopathic) Thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The sNDA application is based on the results from two studies in pediatric chronic ITP, the Phase III PETIT2 study (TRA115450) and the Phase II PETIT study (TRA108062). Eltrombopag, marketed as Promacta in the USA and Revolade in the EU and rest of world, is not approved or licensed anywhere in the world for use in chronic ITP in the pediatric setting.
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