FDA Approves GSK Hepatitis B Drug Bepirovirsen, First ASO for Chronic Hepatitis B

GSK's hepatitis B drug bepirovirsen (brand name Hibsago) has been approved by the FDA for use with existing antiviral therapy in adults with chronic hepatitis B who have no cirrhosis, have received at least 6 months of antiviral treatment, and have HBsAg levels at or below 3000 IU/mL. Hibsago is the first antisense oligonucleotide (ASO) approved by the FDA for chronic hepatitis B; the approval information comes from an FDA press release.