FDA Approves New Add-on Therapy for Chronic Hepatitis B

The FDA has approved GSK's Hibsago (bepirovirsen), an antisense oligonucleotide, as an add-on treatment for adults with chronic hepatitis B virus (HBV) infection already receiving nucleoside analogue therapy. This approval, granted under priority review and Breakthrough Therapy designation, offers a new fixed-duration option. It aims to achieve a functional cure for a subset of patients without cirrhosis, marking a significant advancement in HBV management.