Promacta Gains New Thrombocytopenia Indication

PROMACTA (Eltrombopag) 25mg, 50mg tablets by GlaxoSmithKline
PROMACTA (Eltrombopag) 25mg, 50mg tablets by GlaxoSmithKline

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.

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