FDA OKs Hep C Indication for Promacta
By David Pittman, Washington Correspondent, MedPage Today
Published: November 23, 2012
WASHINGTON -- The FDA has approved eltrombopag (Promacta) for the additional indication of treating low blood platelet counts in patients with chronic hepatitis C.
The treatment will allow those patients who are otherwise poor candidates because of their platelet counts to undergo interferon-based therapy for the liver disease.
The drug was approved in November 2008 to treat low platelet counts -- idiopathic thrombocytopenia purpura -- in chronic sufferers who have had insufficient response to other drugs.
However, eltrombopag should not be used to normalize platelet counts in hepatitis C patients, its manufacturer, GlaxoSmithKline (GSK), said Monday. It should only be used in patients with chronic hepatitis C whose condition prevents them from starting interferon therapy.
Also, safety and efficacy haven't been established in combination with direct-acting antivirals.
Eltrombopag is an oral thrombopoietin receptor agonist that increases platelet count by increasing megakaryocyte differentiation and proliferation. The FDA based its decision on two phase III randomized, double-blinded, controlled studies of more than 1,500 patients with platelet counts less than 75,000.
Overall, 66% of patients treated with eltrombopag plus peginterferon alpha 2a (Pegasys) and ribavirin had an early virologic response, compared with 50% of patients who received peginterferon 2a, ribavirin, and a placebo (P<0.0001), study results found. Additionally, 23% of the eltrombopag group achieved a sustained virologic response versus 14% of the placebo group (P=0.0064).
Eltrombopag carries a boxed warning of causing hepatotoxicity. The drug, in combination with interferon and ribavirin in hepatitis C patients, may increase the risk of hepatic decompensation, the FDA said.
GSK said common side effects in the two trials included anemia, pyrexia, fatigue, and to a lesser extent, peripheral edema.
The drug, known as Revolade outside the U.S., is marketed in 90 countries.
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