GSK has submitted the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for eltrombopag (Revolade), 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.

Characterised by a low platelet count, ITP affects as many as 5 in 100,000 children each year. While many children with acute ITP do not require treatment and/or their disease resolves, up to 30 percent of patients experience persistent disease at 12 months and are diagnosed with chronic ITP. Patients with paediatric chronic ITP are at a risk of severe bleeding.

The EMA submission, 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.

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.

Promacta and Revolade are trademarks of the GSK group of companies.