Promacta Now Approved for Pediatric ITP Patients

Promacta Now Approved for Pediatric ITP Patients
Promacta Now Approved for Pediatric ITP Patients

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.

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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.