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news.AbbVie has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for its investigational, all-oral ribavirin (RBV) and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment for patients with chronic hepatitis C virus (HCV) infection.
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The submission is for treatment of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), dosed once daily in patients with genotype 1 (GT1) HCV infection.
The application is based on data from the Phase III multi-center GIFT-I trial, which evaluated the efficacy and safety of 12 weeks of treatment with OBV/PTV/r in Japanese patients with chronic genotype 1b (GT1b) HCV infection.
According to the company, the trial met its primary endpoint, achieving a 95% sustained virologic response rate at 12 weeks post-treatment (SVR12) in the sub-group of previously untreated, non-cirrhotic, adult GT1b-infected patients who were eligible for therapy with IFN and had a high viral load.
The trial included patients without cirrhosis and with compensated cirrhosis, who were new to therapy or had failed previous treatment with interferon with or without ribavirin.
AbbVie vice president for pharmaceutical development Scott Brun 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 US, 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."
According to the trial, in patients without cirrhosis, the most commonly reported adverse events in the treatment arm were nasopharyngitis, headache and oedema peripheral.