GlaxoSmithKline (GSK) is seeking approval from the European Medicines Agency (EMA) for its eltrombopag (Revolade).
The company has submitted marketing authorisation application for eltrombopag, seeking an additional indication to treat paediatric patients (age one year and above) with chronic immune (idiopathic) thrombocytopenic purpura (ITP), who have had an insufficient response to corticosteroids or immunoglobulins.
According to GSK, the EMA submission was based on results from the Phase III PETIT2 study (TRA115450) and the Phase II PETIT study (TRA108062) in paediatric chronic ITP.
Trials included the registration of a new 25mg powder for oral suspension formulation for eltrombopag and a new 12.5mg tablet.
Marketed as Promacta in the US and Revolade in the EU, eltrombopag has not yet received approval or is licensed in any part of the world to treat chronic ITP in the paediatric setting.
In December 2014, GSK submitted a supplemental new drug application (sNDA) to US Food and Drug Administration (FDA) for eltrombopag (Promacta), seeking additional approval to treat paediatric patients over the age of six with chronic immune ITP.
In November 2014, GSK submitted a marketing authorisation application to the EMA seeking an additional indication for eltrombopag to treat adult patients with severe aplastic anaemia (SAA) who had an insufficient response to immunosuppressive therapy (IST).
The application was submitted based on the results of a pivotal open-label Phase II study (ELT112523) and two supporting Phase II studies (ELT116826 and ELT116643) by the National Institute of Health, assessing eltrombopag in patients with SAA.
Image: GlaxoSmithKline headquarters in Brentford, London, England. Photo: courtesy of Maxwell Hamilton.