logo
Share SHARE
FONT-SIZE Plus   Neg

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

Idenix Pharmaceuticals Inc. (IDIX) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Major League Baseball is talking expansion for the first time in a few decades. Owners stand to make a pretty penny from expansion fees and subsequent television rights. The possibility of a more balanced schedule is also enticing. Strong expansion candidates in the U.S. and Canada are ready... The New York Times is teaming up with Google again to give away Google Cardboard, the virtual reality headsets, but this time only to its "most loyal" digital subscribers. The company said that the digital-only subscribers selected for this distribution were chosen based on the duration of their subscriptions. Oil company Exxon Mobil Corp. on Friday reported a 63 percent fall in profit for the first quarter from last year, while Chevron Corp. reported a loss for the quarter, both on lower revenues. The results were impacted by the fall in crude oil prices and weaker refining margins. However, Exxon Mobil's earnings beat analysts' estimates, while Chevron's loss was wider than their expectations.
comments powered by Disqus
Follow RTT