Hepatitis Social Community
Idenix: FDA Places Hep C Tx on Clinical Hold
About This Community:

This forum is for hepatitis patients, family members, loved ones, friends or anyone with an interest in hepatitis, to have open social conversations about any topic they choose, with the exception of religion and politics. Please note that our standard “Rules for Posting in Public Areas”, which are found in our Terms of Use , also apply in this community. If you are newly diagnosed with Hepatitis or you have questions or information to share about current treatments, research studies, clinical trials, or other medical issues pertaining to Hepatitis, please post it in one of our Hepatitis Communities ( Hep A , Hep B , Hep C or Hep-autoimmune ).

Font Size:
A
A
A
Background:
Blank
Blank
Blank
Blank Blank

Idenix: FDA Places Hep C Tx on Clinical Hold


Idenix: FDA Places Hepatitis C Treatment on Clinical Hold

Published August 27, 2012

Dow Jones Newswires

Idenix Pharmaceuticals Inc. (IDIX) said the Food and Drug Administration placed a clinical hold on one of its treatments for hepatitis C, the latest setback for the drug developer.

The clinical hold on the treatment--IDX19368--is related to the regulator's heart-safety concerns about rival Bristol-Myers Squibb Co.'s (BMY) closely watched treatment for the liver disease, which belongs to the same class of drugs--known as nucleotide polymerase inhibitors.

Idenix earlier this month had seen the FDA place a partial hold on further trials of another hepatitis C treatment, IDX184, also following concerns about the Bristol-Myers treatment. On Monday, Idenix said the FDA has also requested additional cardiac testing of patients in a continuing Phase IIb trial of IDX184. The company said it is set to submit the data in coming weeks.

Bristol-Myers last week said it had stopped development of its treatment, known informally as 094, after one patient died in testing and eight others were hospitalized.

Idenix said that no patients have been exposed to IDX19368. President and Chief Executive Ron Renaud also said that while both of its compounds fall into the same broader class, "there are many attributes of our compounds, particularly the prodrug approach, that we believe favorably differentiate the toxicity profiles" from the Bristol-Myers drug.

Mr. Renaud said "Bristol-Myers Squibb has agreed to share relevant information on BMS-986094 with us and hope this helps us to resolve this issue quickly."

The company had submitted an investigational new drug application for IDX19368 with the FDA in the current quarter, a period in which it also had planned to begin a clinical trials.

Hepatitis C is a blood-borne virus that afflicts an estimated four million Americans and 170 million people world-wide. The disease is often contracted during sex or by sharing needles and at tattoo parlors. Left untreated, it can require a liver transplant and eventually prove fatal.

Current treatment of the disease requires long courses of painful injections and often doesn't work. Drug makers have been racing to find pills that are both more potent and easier to take.

Read more: http://www.foxbusiness.com/news/2012/08/27/idenix-fda-places-hepatitis-c-treatment-on-clinical-hold/#ixzz24miYoeCP

   *************************************************************************************************************

Here we go again!
Post a Comment
To
Blank
Weight Tracker
Weight Tracker
Start Tracking Now
Hepatitis Social Community Resources
RSS Expert Activity
242532_tn?1269553979
Blank
Control Emotional Eating with this ...
Sep 04 by Roger Gould, M.D.Blank
242532_tn?1269553979
Blank
Emotional Eating Control: How to St...
Aug 28 by Roger Gould, M.D.Blank
233488_tn?1310696703
Blank
New Cannabis Article from NORTH Mag...
Jul 20 by John C Hagan III, MD, FACS, FAAOBlank
Top Hepatitis Answerers
Avatar_m_tn
Blank
can-do-man
IN
766573_tn?1365170066
Blank
Idyllic
163305_tn?1333672171
Blank
orphanedhawk
Rural Mural, CA
683231_tn?1408489117
Blank
flyinlynn
Auburn, WA
Avatar_f_tn
Blank
susan400
FL
1815939_tn?1377995399
Blank
pooh55811