Promacta is a once-daily oral thrombopoietin (TPO) receptor agonist that works by inducing stimulation and differentiation of megakaryocytes from bone marrow stem cells to increase platelet production.
The company noted that the updated label also includes a new oral suspension formulation of Promacta which is designed for younger children who may not be able to swallow tablets.
This June, FDA approved Promacta as a tablet formulation for children six years of age and older and in 2008 for use in adult patients with the same condition.
ITP, which is characterized by a low platelet count, affects as many as five in 100,000 children each year.
Novartis Oncology president Bruno Strigini said: "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.
"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."
The approval was based on data from two double-blind, placebo-controlled trials, including the largest Phase III clinical trial in this patient population.
The trials showed that treatment with Promacta increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids.