FDA Approves GSK's Bepirovirsen Injection with Nucleos(t)ide Analogues for Certain Adults with Chronic Hepatitis B

On October 20, 2026, GSK announced FDA approval of bepirovirsen injection (Hibsago) in combination with nucleos(t)ide analogues for adults with chronic hepatitis B. Eligible patients must have received at least 6 months of antiviral therapy, have suppressed virus, confirmed HBsAg no more than 3000 IU/mL by an FDA-authorized assay, and no cirrhosis. According to the source, the United States is now the second country or region worldwide to approve the drug for chronic hepatitis B.