GSK files for EU expanded indication for Revolade

UK pharma major GlaxoSmithKline (LSE: GSK) has filed a submission with the European Medicines Agency for a variation to the Marketing Authorization for Revolade (eltrombopag), seeking an additional indication for the treatment of pediatric patients (age one year and above) with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids or immunoglobulins.

Characterized 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% 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.

Clinical backing

The EMA submission, based on the results from the Phase III PETIT2 study (TRA115450) and the Phase II PETIT study (TRA108062) in pediatric chronic ITP, includes the registration of a new 25mg Powder for Oral Suspension formulation for eltrombopag, as well as a new 12.5mg tablet.