Idenix Pharmaceuticals Inc. (IDIX) said the U.S. Food and Drug Administration or FDA has granted Fast Track designation for IDX719 for chronic hepatitis C infection or HCV treatment. IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent proof-of-concept clinical trial in genotypes 1-4, treatment-naive HCV patients.
Ron Renaud, President and Chief Executive of Idenix noted, "We remain focused on executing our goal of creating an interferon-free direct acting antiviral combination to cure HCV for a patient population that currently has limited treatment options. As previously reported, we are on track to initiate a phase II combination study of IDX719 with IDX184, our other lead HCV product candidate, by the end of this year."
As per the FDA Modernization Act of 1997, Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening condition and that shows the potential to address an unmet medical need for such a condition. The Fast Track program enables a company to file a New Drug Application on a rolling basis.
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