GSK's Hibsago Receives US FDA Approval for Chronic Hepatitis B

GSK plc announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection. This first-in-class antisense oligonucleotide (ASO) is approved for use in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, who have suppressed HBV DNA and specific hepatitis B virus surface antigen levels. The approval, granted under FDA priority review and Breakthrough Therapy Designation, offers the potential for functional cure after a six-month treatment course.