Promacta Gains New Thrombocytopenia Indication
GlaxoSmithKline announced that the FDA has approved Promacta (eltrombopag tablets) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. This is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts.
The new indication approval is based on results from two Phase 3 studies: ENABLE 1 and ENABLE 2 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE). These randomized, double-blind, placebo-controlled, multicenter studies enrolled 1,521 patients with platelet counts <75,000/µL. ENABLE 1 utilized peginterferon alfa-2a (Pegasys; Roche) plus ribavirin for antiviral treatment, and ENABLE 2 utilized peginterferon alfa-2b (Peg-Intron; Merck) plus ribavirin.
Promacta is a thrombopoietin receptor agonist approved as a treatment for thrombocytopenia due to chronic immune (idiopathic) thrombocytopenic purpura (ITP) in adults who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.For more information call (888) 593-5977 or visit www.promacta.com.