Aa
A
A
Close
446474 tn?1446351282
FDA OKs Hep C Indication for Promacta
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.


hector
Cancel
1 Answers
1 Answers
Page 1 of 1
1815939 tn?1377995399
Thanks for posting that article, Hector.
Comment
Cancel
1815939 tn?1377995399
Comment
Comment
Submit Comment
Your Answer
446474 tn?1446351282
Answer
Know how to answer? Tap here to leave your answer...
Answer
Submit Answer
A
A
Recent Activity
17898896 tn?1461338516
Blank
Canady74 Confused Comment
Apr 29
675718 tn?1449992146
Blank
drifter0213 commented on advanced niTD
Apr 28
4730868 tn?1362623278
Blank
Theobaldm1989 commented on advanced niTD
Apr 28
Blank
Weight Tracker
Track your weight over time
Start Tracking Now
Top Hepatitis Answerers
446474 tn?1446351282
Blank
HectorSF
San Francisco, CA
1815939 tn?1377995399
Blank
pooh55811
683231 tn?1438659664
Blank
flyinlynn
Auburn, WA
317787 tn?1460223707
Blank
Dee1956
DC
Avatar m tn
Blank
can-do-man
IN
163305 tn?1333672171
Blank
orphanedhawk
Rural Mural, CA
Hepatitis Social Community Resources
RSS Expert Activity
233488 tn?1310696703
Blank
Marathon Running Done Over Many Yea...
May 21 by John C Hagan III, MD, FACS, FAAOBlank
233488 tn?1310696703
Blank
New Article on Multifocal IOL vs &q...
May 21 by John C Hagan III, MD, FACS, FAAOBlank
748543 tn?1443740527
Blank
TMJ/TMJ The Connection Between Teet...
01/15 by Hamidreza Nassery , DMD, FICOI, FAGD, FICCMOBlank
Top Hepatitis Answerers
446474 tn?1446351282
Blank
HectorSF
San Francisco, CA
1815939 tn?1377995399
Blank
pooh55811
683231 tn?1438659664
Blank
flyinlynn
Auburn, WA
317787 tn?1460223707
Blank
Dee1956
DC
Avatar m tn
Blank
can-do-man
IN
163305 tn?1333672171
Blank
orphanedhawk
Rural Mural, CA