GSK requests additional authorisation in EU for Revolade in ITP - GSK
GlaxoSmithKline has announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for Revolade (eltrombopag), seeking an additional indication for the treatment of paediatric patients (age 1 year and above) with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids or immunoglobulins.
The EMA submission is based on the results from the Phase III PETIT2 study (TRA115450) and the Phase II PETIT study (TRA108062) in paediatric chronic ITP, includes the registration of a new 25 mg powder for oral suspension formulation for eltrombopag, as well as a new 12.5 mg tablet.
Comment: 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 paediatric setting.
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