Novartis' Promacta approved in pediatric chronic immune thrombocytopenia

The US Food and Drug Administration has approved Promacta (eltrombopag) from Swiss drug company Novartis (NOVN: VX), for the treatment of children aged six years and older with chronic immune thrombocytopenia (ITP) who have insufficient response to corticosteroids, immunoglobins or splenectomy.

The drug was approved by the FDA in 2008 for the same indication in adult patients. ITP is characterized by a low platelet count, and pediatric patients with chronic ITP are at ongoing risk of significant bleeding.

The approval was based on data from two double-blind, placebo-controlled trials, including the largest Phase III trial carried out in this patient population. Promacta treatment significantly increased and sustained platelet counts among some pediatric patients with chronic ITP. Some patients taking concomitant ITP medications were able to reduce or discontinue these medications, particularly those taking corticosteroids.