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news.AbbVie has filed a new drug submission (NDS) to Health Canada seeking approval for its investigational, all-oral, interferon-free regimen to treat adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with cirrhosis.
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The investigational regimen consists of the 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.
The NDS is supported by data from the all-oral, interferon-free clinical program in GT1 patients with six Phase III trials that included over 2,300 patients in over 25 countries.
AbbVie Canada general manager Felipe Pastrana said the latest regulatory submission is yet another significant achievement for the company’s HCV development program.
"Our all-oral, interferon-free regimen offers adults living with genotype 1 chronic hepatitis C a promising solution to a worldwide problem," Pastrana said.
In May 2014, Health Canada approved the company’s request for priority evaluation for its investigational direct-acting antiviral (DAA) regimen with and without ribavirin for HCV genotype 1.
The company said that an informal Bureau Adjudicating Committee reviewed the request and concluded that the regimen fulfilled the criteria for Priority Evaluation.