FDA Approves Hibsago (Bepirovirsen) for Chronic Hepatitis B

The U.S. Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen), an antisense oligonucleotide developed by GSK, for adults with chronic hepatitis B virus (HBV) infection. This approval is for use as an add-on therapy for patients without cirrhosis who are already on nucleoside analogue therapy, have suppressed viral loads, and specific surface antigen levels. The decision follows priority review and Breakthrough Therapy designation, offering a new fixed-duration treatment option aimed at achieving functional cure, which is rarely accomplished with suppressive therapy alone.