Chronic hepatitis C: Promacta for patients with thrombocytopenia to allow the initiation and maintenance of Interferon-based therapy
GlaxoSmithKline ( GSK ) has announced that the FDA ( Food and Drug Administration ) has approved Promacta ( Eltrombopag; in Europe: Revolade ) 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 treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts.
Eltrombopag in combination with Interferon-based therapy has been shown to improve a patient's chance of achieving a sustained virologic response ( SVR ) or viral cure.
There are limitations to the use of Promacta in patients suffering from chronic hepatitis C-associated thrombocytopenia. These include: Eltrombopag should not be used in an attempt to normalize platelet counts; Eltrombopag should be used only in 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; and safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.
The approval for Promacta is based on results from ENABLE 1 and 2 ( Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE ), two Phase III randomized, double-blind, placebo-controlled, multicenter studies, which collectively enrolled 1,521 patients with platelet counts less than 75,000/microL. ENABLE 1 utilized Peginterferon alfa-2a ( Pegasys ) plus Ribavirin for antiviral treatment and ENABLE 2 utilized Peginterferon alfa-2b ( PegIntron ) plus Ribavirin.
Eltrombopag, marketed under the brand names Promacta in the United States and Revolade in Europe and Rest-of-World, is a thrombopoietin receptor agonist approved in 90 countries around the world as a treatment for thrombocytopenia in patients with chronic immune ( idiopathic ) thrombocytopenic purpura ( ITP ).
In the United States, Promacta is already indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. ( Xagena )
Source: GSK, 2012