UPDATE: Idenix (IDIX) IDX184 Placed on Partial Clinical Hold After Serious Cardiac-Related Event
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(Updated - August 16, 2012 8:08 AM EDT)
Idenix Pharmaceuticals Inc. (Nasdaq: IDIX) announced that hepatitis C drug IDX184 has been placed on partial clinical hold by the FDA due to a serious cardiac-related adverse event.
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 FDA has requested additional data on patients treated with IDX184, which the company expects to submit in the coming weeks.
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Idenix Pharmaceuticals Inc. (Nasdaq: IDIX) announced that hepatitis C drug IDX184 has been placed on partial clinical hold by the FDA due to a serious cardiac-related adverse event.
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 FDA has requested additional data on patients treated with IDX184, which the company expects to submit in the coming weeks.
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