NDA for Chronic Genotype 1 HCV Accepted for Priority Review
Enanta Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) for priority review for AbbVie's all-oral, interferon-free regimen in the treatment of adults with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
The investigational regimen consists of a fixed-dose combination of boosted protease inhibitor ABT-450/ritonavir (150mg/100mg), NS5A inhibitor ombitasvir (ABT-267) 25mg, and non-nucleoside polymerase inhibitor dasabuvir (ABT-333) 250mg with or without ribavirin.
The NDA is supported by data from a large clinical program being conducted by AbbVie, including six Phase 3 studies of more than 2,300 GT1 patients. Previously the regimen was granted Breakthrough Therapy designation by the FDA in May 2013.
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