AbbVie has submitted a New Drug Application in Japan seeking approval to market its investigational, oral treatment for patients with genotype 1 chronic hepatitis C.

The ribavirin and interferon-free therapy is a fixed-dose combination of paritaprevir/ritonavir and ombitasvir - dosed once daily for 12 weeks - offering two direct-acting antivirals each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.

The submission is backed by data from the Phase III GIFT-I trial, which met its primary endpoint achieving 95% sustained virologic response rate at 12 weeks post-treatment.

The move also closely follows approvals in Europe, the US and Canada for a three-antiviral combo; the two direct-acting antiviral regimen without RBV is being studied in Japan because of patient and viral characteristics specific to the Japanese population, the firm noted.