GSK announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for eltrombopag (Promacta), seeking an additional indication in paediatric patients six years and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
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 per cent 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 sNDA application is based on the results from two studies in paediatric chronic ITP, the phase III PETIT2 study (TRA115450) and the phase II PETIT study (TRA108062).
Eltrombopag, marketed as Promacta in the USA and Revolade in the EU and rest of world, is not approved or licenced anywhere in the world for use in chronic ITP in the paediatric setting.