FDA Approves GSK's Hibsago for Chronic Hepatitis B Treatment

The U.S. FDA has granted approval to GSK's Hibsago (bepirovirsen), a first-in-class antisense oligonucleotide, for treating chronic hepatitis B virus (HBV) infection in specific adult patients. This approval, under Priority Review and Breakthrough Therapy Designation, applies to adults without cirrhosis who are on NrtI therapy, have suppressed HBV DNA, and particular hepatitis B virus surface antigen levels.