EC Oks Pediatric Use for Novartis’ Revolade

The European Commission (EC) has approved Novartis’ Revolade (eltrombopag) for the treatment of pediatric (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[2],[3]. 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.

The EC approval applies to all 28 EU member states, plus Iceland, Norway, and Liechtenstein.

Revolade is a once-daily oral thrombopoietin (TPO) receptor agonist that works by inducing stimulation and differentiation of megakaryocytes (large cells, found especially in bone marrow) from bone marrow stem cells to increase platelet production. In August 2015, the US Food and Drug Administration (FDA) approved a new oral suspension formulation, which expanded use of eltrombopag (marketed as Promacta in the US) to include children 1 year of age and older with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

Revolade is also approved in over 45 countries worldwide for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. In September 2015, the EC approved Revolade for the treatment of adults with severe aplastic anemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplant.

Source: Novartis

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