NDA Submitted for All-Oral, Interferon-Free Hepatitis C Regimen
AbbVie announced that it has submitted a New Drug Application (NDA) to the FDA for an investigational, all-oral, interferon-free regimen for the treatment of adults with chronic genotype (GT1) hepatitis C virus (HCV) infection.
The investigational regimen consists of a fixed-dose combination of boosted protease inhibitor ABT-450/ritonavir (Enanta Pharmaceuticals), NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333 with or without ribavirin.
The NDA submission was supported by AbbVie's data from the largest all-oral, interferon-free clinical trial program in GT1 HCV patients, with six Phase 3 studies that included over 2,300 patients.
In May of 2013, The FDA designated AbbVie's investigational direct-acting antiviral (DAA) regimen with and without ribavirin for HCV genotype 1 as a Breakthrough Therapy.
For more information call (617) 607-0800 or visit Enanta.com.