AbbVie's Chronic Hepatitis C Treatment Granted Priority Review In Japan

(RTTNews) - AbbVie (ABBV) said Wednesday that the Japanese Ministry of Health, Labour and Welfare or MHLW has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir.

This all-oral treatment is interferon or IFN and ribavirin or (RBV-free and will be dosed once daily. The MHLW grants priority review to certain medicines on the basis of clinical usefulness and severity of the disease, including diseases like hepatitis C, which affects approximately 1.5 to 2 million people in Japan.

AbbVie's investigational hepatitis C treatment was submitted for marketing approval in Japan in February 2015. The New Drug Application is for the treatment of patients with genotype 1 or GT1 chronic hepatitis C virus or HCV infection and is supported by the Phase 3 GIFT-I study in Japanese genotype 1b or GT1b HCV patients.

AbbVie studied a two direct-acting antiviral treatment regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b. In Japan, GT1 is the most common HCV genotype and accounts for 60 to 70 percent of all patients infected with HCV.2 Of those patients, about 95 percent are infected with the GT1b sub-type.