FDA approves expanded use for Novartis’ Promacta

SILVER SPRING, Md. — The FDA this week expanded the use for Novartis’ Promacta (eltrombopag), which it had approved in June to treat chronic immune thrombocytopenia in adults and children 6 years of age and older. Now, the drug can be used in children 1 year of age and older with ITP who have not had a sufficient response to a splenectomy, immunoglobulins or corticosteroids.

“It’s challenging and often very emotional for parents of a baby or toddler affected by a rare condition to manage their child’s disease with limited treatment options,” Novartis Oncology president Bruno Strigini said. “Today’s label expansion for Promacta provides a new disease management option for families affected by chronic ITP and highlights our commitment to providing treatments for even the youngest children with rare diseases.” 

Promacta is available in 25-, 50- and 75-mg dosage strength tablets.