FDA approves Novartis’ Promacta for pediatric use

EAST HANOVER, N.J. — Novartis announced Friday that the Food and Drug Administration had granted approval to its drug Promacta (eltrombopag) to treat children 6 and older for chronic immune thrombocytopenia (ITP). 

 

The drug is a daily oral treatment for ITP, an illness in which the patient has a low blood platelet count for more than six months, putting them at increased risk of significant bleeding. Promacta was approved for adult use by the FDA in 2008

 

“Today’s FDA approval of Promacta for children with chronic ITP, a rare and potentially serious blood disorder, gives new hope to patients and their families,” Novartis Oncology president Bruno Strigini said. “All patients are important, but when we can help children, we are especially gratified. This approval underscores our expertise in benign hematologic disease and our commitment to provide treatments for rare diseases.”