AbbVie submits NDA to Japanese regulators for ombitasvir/ paritaprevir/ ritonavir combination in hepatitis C

US drugmaker AbbVie (NYSE: ABBV) has submitted a New Drug Application to the Japanese Ministry of Health, Labor and Welfare for its ombitasvir/paritaprevir/ritonavir combination for genotype 1 chronic hepatitis C infection.

The combination is an investigational, all-oral, ribavirin- and interferon-free, 12-week, direct-acting antiviral treatment dosed once-daily. The NDA is supported by the Phase III GIFT-I study, which met its primary endpoint. It achieved a 95% sustained virologic response rate at 12 weeks post-treatment in the subgroup of previously untreated, non-cirrhotic, adult genotype 1b-infected Japanese patients who were eligible for therapy with IFN and had a high viral load. Two patients without cirrhosis discontinued treatment due to adverse events.

Scott Brun, vice president of pharmaceutical development at AbbVie, said: "We are pleased to announce the regulatory submission of our two direct-acting hepatitis C antiviral treatment in Japan, which follows on quickly from recent approvals of our three direct-acting antiviral treatment in the USA, Canada and the European Union. This submission is based on a large Phase III study in multiple patient types and brings us closer to offering the possibility of cure for patients with chronic genotype 1b hepatitis C infection, the most common form of the disease in the country."