Novartis announced that the Food and Drug Administration (FDA) has approved Promacta (eltrombopag) for the treatment of thrombocytopenia in children aged ≥6 years with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
The approval was based on data from two double-blind, placebo-controlled trials that included the largest Phase 3 clinical trial in this patient population. Promacta significantly increased and sustained platelet counts among some pediatric patients with chronic ITP; in some patients taking concomitant ITP medications, they were able to reduce or discontinue use of these medications, especially corticosteroids.
Promacta, a thrombopoietin receptor agonist, is already indicated for the treatment of thrombocytopenia in patients with: chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy; severe aplastic anemia who have had an insufficient response to immunosuppressive therapy; and chronic ITP in adults who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
For more information call (888) 825-5249 or visit Promacta.com.