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.
Copyright 1994-2016 MedHelp International. All rights reserved.
MedHelp is a division of Aptus Health.
This site complies with the HONcode standard for trustworthy health information.
The Content on this Site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease; or a recommendation for a specific test, doctor, care provider, procedure, treatment plan, product, or course of action. Med Help International, Inc. is not a medical or healthcare provider and your use of this Site does not create a doctor / patient relationship. We disclaim all responsibility for the professional qualifications and licensing of, and services provided by, any physician or other health providers posting on or otherwise referred to on this Site and/or any Third Party Site. Never disregard the medical advice of your physician or health professional, or delay in seeking such advice, because of something you read on this Site. We offer this Site AS IS and without any warranties. By using this Site you agree to the following Terms and Conditions. If you think you may have a medical emergency, call your physician or 911 immediately.