Novartis announced today that the US Food and Drug Administration (FDA) has approved Promacta (eltrombopag olamine) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was approved by the FDA in 2008 for use in adult patients with the same condition. 

ITP affects as many as 5 in 100,000 children each year and is characterized by a low platelet count[1]. Up to 30% of affected children experience persistent disease for more than 6 months and are diagnosed with chronic ITP. Pediatric patients with chronic ITP are at ongoing risk of significant bleeding. 

"Young patients with chronic ITP who have either an insufficient response to or side effects from standard therapies have limited treatment options, making this FDA approval of eltrombopag for children six years and older particularly important," said James B. Bussel, MD, a professor of pediatrics, of pediatrics in obstetrics and gynecology and of pediatrics in medicine at Weill Cornell Medical College, and lead study investigator of the PETIT study. "Through the eltrombopag studies, one of which is the largest randomized trial ever performed in children with chronic ITP, we discovered that Promacta - a treatment that can be taken once daily by mouth and shown to be well tolerated - can manage this disorder and help these young patients."

For more details, go to: https://www.novartis.com/news/media-releases/novartis-gains-fda-approval-promacta®-providing-new-option-children-ages-6-and