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
Swiss banking giant UBS Group AG (UBS) reported Friday an increased pre-tax profit for the third quarter despite weakness in net interest income. Net profit, however, decreased on the absence of last year's hefty tax benefit. Looking ahead, UBS said it is unlikely that the underlying macroeconomic uncertainty and geopolitical tensions will change in the foreseeable future. Amazon.com Inc. (AMZN) Thursday reported an increase in profit for the third quarter, driven largely by revenue growth, especially at Amazon Web services. However, shares of the online retailer dropped nearly 5 percent in extended session after its profit fell short of Wall Street estimates. The midpoint... Alphabet Inc., (GOOG, GOOGL), the parent company of Google, Thursday reported a jump in third-quarter profit, largely driven by increase in search and advertising revenues. Earnings and revenues for the quarter trumped Wall Street expectations. Alphabet's third-quarter profit rose to $5.06 billion...
comments powered by Disqus
Follow RTT