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FDA Approves Promacta for Pediatric Patients with Chronic Immune Thrombocytopenia

Posted: June 30, 2015

(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.

FDA Approves Promacta for Pediatric Patients with Chronic Immune Thrombocytopenia was last modified: June 10th, 2016 by Geoff Duncan

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