(Healio) – The FDA announced the approval of eltrombopag for use in children aged 6 years or older with chronic immune thrombocytopenia who experienced an insufficient response to corticosteroids, immunoglobulins or splenectomy, according to a press release.
Eltrombopag (Promacta, Novartis) is a once-daily oral thrombopoietin receptor agonist that increases platelet production in patients with chronic immune thrombocytopenia, according to a press release. The FDA approved eltrombopag for use in adults in 2008.
Immune thrombocytopenia affects up to five in 100,000 children annually. Approximately 30% of affected children experience persistent disease for more than 6 months and are diagnosed with chronic immune thrombocytopenia. Pediatric patients face a risk for significant bleeding.
The most common treatments for chronic immune thrombocytopenia — including corticosteroids and IV immunoglobulin — often result in intolerable adverse events for pediatric patients, according to the press release.