Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for AbbVie's investigational product ombitasvir/paritaprevir/ritonavir to treat chronic hepatitis C.
Subscribe to our email newsletter
According to the company, this all-oral treatment is interferon (IFN) and ribavirin (RBV)-free and will be dosed once daily.
In February 2015, the company submitted a new drug application (NDA) for its investigational hepatitis C treatment for marketing approval in Japan.
The NDA is for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection and is based on the Phase III GIFT-I trial in Japanese genotype 1b (GT1b) HCV patients.
AbbVie pharmaceutical development vice-president Scott Brun said: "AbbVie is pleased that the Japanese MHLW has granted priority review for our interferon and ribavirin-free, 12-week, two direct-acting antiviral treatment regimen.
"This marks another important advancement in our HCV clinical development program as we aim to provide our HCV treatment to patients across the world.
"If approved, AbbVie’s HCV treatment holds the potential to be a promising new treatment option for patients living with this chronic infection in Japan."
The company 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.