Novartis announced that the Food and Drug Administration (FDA) has approved Promacta (eltrombopag) for the treatment of thrombocytopenia in children >1 year of age with chronic immune thrombocytopenia (ITP) who have not achieved an adequate response to corticosteroids, immunoglobulins, or splenectomy.
The approval was based on two double-blind, placebo-controlled trials of 159 pediatric patients aged 1–17 years with chronic ITP. The primary endpoint was an increase in platelet counts and in both trials, Promacta significantly raised platelet levels without requiring rescue therapy. The trials also showed that patients on Promacta also had less need for other ITP treatments and about half of the participants were able to reduce or discontinue those medications, chiefly corticosteroids.
Promacta is a thrombopoietin receptor agonist, already indicated for the treatment of thrombocytopenia in patients >6 years of age who have had an inadequate response to other ITP medications or splenectomy, severe aplastic anemia in adults who have had insufficient response to immunosuppressive therapy, and thrombocytopenia in adults with chronic hepatitis C to allow initiation and maintenance of interferon-based therapy.
Promacta is available in 12.5mg, 25mg, 50mg, 75mg, and 100mg-strength tablets and as a powder for oral suspension in children aged 1–5 years.
For more information call (888) 825-5249 or visit Promacta.com.