The US Food and Drug Administration (FDA) has granted fast track designation for Idenix Pharmaceuticals' IDX719 to treat chronic hepatitis C infection (HCV).
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.
Idenix president and chief executive officer Ron Renaud said the receipt of fast track designation from the FDA for IDX719 reflects the critical need for new treatment regimens to address HCV infection.
"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," Renaud added.
The fast track program allows a company to file a new drug application on a rolling basis, which permits the FDA to review the filing as it is received, rather than waiting for the entire submission prior to commencing the review process.
