GlaxoSmithKline applies for EU approval of new Revolade indication

GlaxoSmithKline has filed for approval of a new indication of its drug Revolade from the European Medicines Agency.

The company is seeking a variation to the marketing authorisation for the eltrombopag-based therapy, which would allow it to be used in the treatment of paediatric patients with idiopathic thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids or immunoglobulins.

This filing is supported by positive safety and efficacy data from the phase II Petit study and the phase III Petit 2 trial. GlaxoSmithKline is hoping to launch a new 25 mg powder formulation of the drug for oral suspension, as well as a new 12.5 mg tablet.

ITP affects as many as five in 100,000 children each year and is characterised by a low platelet count. Patients with paediatric chronic ITP are at a heightened risk of severe bleeding incidents.

While many children with acute ITP do not require treatment and see their condition eventually resolve itself, up to 30 percent of patients experience persistent disease at 12 months and are diagnosed with chronic ITP.

This latest filing comes after the firm also applied for EU approval Revolade as a treatment for severe aplastic anaemia last year.