GSK announced it has received its first global regulatory approval for Hibsago (bepirovirsen) in Japan. The drug is the first and only approved treatment in the country that can provide a "functional cure" for chronic hepatitis B (CHB) in certain adult patients. This is a significant development as current treatments typically only suppress the virus rather than eliminating it.
The approval by Japan's Ministry of Health, Labour and Welfare was based on Phase III trials where the drug showed a functional cure rate of 19% in a specific patient group, a substantial improvement over the 1% rate for existing standard-of-care therapies. A functional cure means the virus is undetectable 24 weeks after treatment stops. Nearly one million people in Japan live with CHB, a leading cause of liver cancer.