Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Idenix Pharma Says IDX184 Placed On Partial Clinical Hold By FDA - Quick Facts

Idenix Pharmaceuticals Inc. (IDIX: Quote) announced that it received verbal notice from the U.S. Food and Drug Administration or FDA that a partial clinical hold has been placed on IDX184, the Company's nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (HCV).

As a result of the recent occurrence of a serious cardiac-related adverse event encountered with a competitor's nucleotide polymerase inhibitor for the treatment of HCV, the FDA has expressed an interest in further reviewing the safety of IDX184 and has placed IDX184 on partial clinical hold.

In previous clinical trials as well as the ongoing phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV), there has been no evidence to date of cardiotoxicity in patients dosed with IDX184 with PegIFN/RBV beyond that seen with PegIFN/RBV alone. There are currently no patients receiving IDX184 worldwide.

The company noted that the FDA has requested additional data on patients treated with IDX184. Patient safety is our main concern and Idenix will immediately begin work to comply with the FDA request and expects to submit these data to the FDA in the coming weeks.

The company noted that it intends to have an ongoing discussion with the FDA following the submission of this data.

Register
To receive FREE breaking news email alerts for Idenix Pharmaceuticals Inc and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
After initially showing a lack of direction, stocks have moved mostly higher over the course of the trading day on Friday. With the gains on the day, the markets are extending the upward trend seen over the past several sessions. In another troubling sign for Democrats, the results of a Gallup poll released on Friday show that Tea Party Republicans are much more motivated to vote in the upcoming midterm elections than other Americans. The poll found that 73 percent of Tea Party Republicans are "extremely" or "very" motivated to vote in this year's elections. While the Commerce Department released a report on Friday showing a modest increase in new home sales in the U.S. in the month of September, the uptick came from a significantly downwardly revised level in August.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.