Chronic hepatitis C treatment given priority review in Japan
The treatment is for ombitasvir/paritaprever/ritonavir, an oral medication that is free of ribavirin (RBV) and interferon (IFN). The medication is administered in single daily doses.
The MHLW only gives specific medicines priority review based on their clinical usefulness as well as the severity of the disease they treat. In this case, chronic hepatitis C infections affect approximately 1.5 million to 2 million people in Japan.
AbbVie submitted its investigational hepatitis C treatment for marketing approval in Japan in February .
"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," Dr. Scott Brun, vice president for pharmaceutical development at AbbVie, said. "This marks another important advancement in our HCV (hepatitis C virus) 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."