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news.US-based biopharmaceutical firm AbbVie has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for its investigational, all-oral, interferon-free regimen to treat adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
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The NDA submission was based on data from the largest Phase III program in GT1 patients conducted to date, with six Phase III studies that included over 2,300 patients in about 25 countries.
AbbVie vice president of Pharmaceutical Development Scott Brun said the NDA submission is a significant advancement for the company’s HCV development program.
"Based on the robust data that have been generated in our international Phase III HCV program, we believe our all-oral, interferon-free regimen holds the potential to be a promising new therapy for patients living with this chronic infection," Brun said.
In May of 2013, the company’ investigational direct-acting antiviral (DAA) regimen with and without ribavirin for HCV genotype 1 was designated as a breakthrough therapy by the FDA.
The company intends to submit applications for regulatory approval of its regimen in the European Union (EU) in early May 2014.
The AbbVie investigational regimen includes fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without RBV (weight-based), dosed twice daily.