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FDA Approves New Indication for Promacta (Eltrombopag) in Patients With Chronic Hepatitis

Supportive care allows patients to initiate interferon-based therapy (Nov. 19)

The FDA has approved Promacta (eltrombopag, GlaxoSmithKline) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. Promacta is the first supportive-care drug available to patients who are ineligible or poor candidates for interferon-based therapy because of their low platelet counts.

There are limitations to the use of Promacta in patients with chronic hepatitis C- associated thrombocytopenia. The drug should not be used in an attempt to normalize platelet counts. It should be administered only to patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy. The safety and efficacy of Promacta have not been established in combination with direct-acting antiviral agents approved for the treatment of chronic hepatitis C genotype-1 infection.

The approval of Promacta is based on results from the ENABLE 1 and 2 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects With Hepatitis C-Related Liver DiseasE) trials — two phase III randomized, double-blind, placebo-controlled, multicenter studies that enrolled a total of 1,521 patients with platelet counts < 75,000/mcL. The ENABLE 1 trial used peginterferon alfa-2a (Pegasys, Genentech) plus ribavirin for antiviral treatment, and the ENABLE 2 study used peginterferon alfa-2b (Pegintron, Merck Sharp & Dohme) plus ribavirin.

Eltrombopag is a thrombopoietin receptor agonist approved in 90 countries as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP). In the U.S., Promacta (eltrombopag) is indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Source: GlaxoSmithKline; November 19, 2012.

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