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news.GlaxoSmithKline (GSK) has submitted a variation to the Marketing Authorization to the European Medicines Agency (EMA) seeking an additional indication for eltrombopag (Revolade) to treat paediatric patients aged one year and above with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
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The EMA submission includes the registration of a new 25mg Powder for Oral Suspension formulation for eltrombopag and also a new 12.5mg tablet.
The drug is indicated to treat these ITP patients who have had an insufficient response to corticosteroids or immunoglobulins.
ITP is characterized by a low platelet count and each year it affects as many as five in 100,000 children.
The submission is based on the results from the Phase III PETIT2 study and the Phase II PETIT study (TRA108062) in paediatric chronic ITP.
Eltrombopag is marketed as Promacta in the US and Revolade in the EU and rest of world, while the drug is not approved or licensed anywhere in the world for use in chronic ITP in the paediatric setting.