EU approves use of Revolade (eltrombopag) in paediatric patients for treatment of chronic immune (idiopathic) thrombocytopenic purpura .- Novartis

Novartis has announced that the European Commission (EC) has approved Revolade (eltrombopag) for the treatment of paediatric (aged 1 year and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). The approval includes the use of tablets as well as a new oral suspension formulation of Revolade, which is designed for younger children who may not be able to swallow tablets.

Revolade was approved by the EC in 2010 for use in adults with the same condition. ITP is a rare blood disorder that affects about five in 100,000 children each year and is characterized by a low platelet count. Because people with ITP have a low number of platelets, they may bruise easily and experience bleeding that is hard to stop. Chronic ITP, defined as ongoing disease more than 12 months after diagnosis, occurs in 13-36% of children with ITP. A small number of pediatric patients with chronic ITP may be at risk of significant bleeding.