GSK Wins US FDA Approval for Chronic Hepatitis B Treatment Hibsago

12:06 AM EDT, 10/21/2026 (MT Newswires) -- GSK (GSK.L) secured US approval for Hibsago, in combination with existing antiviral therapy, to treat chronic hepatitis B virus infection in certain adults without cirrhosis, according to a Tuesday release. Hibsago, or bepirovirsen, is the first antisense oligonucleotide cleared by the US Food and Drug Administration for chronic hepatitis B. It is also indicated for patients who have been taking antiviral therapy for at least six months, have suppressed levels of hepatitis B virus in their blood and have hepatitis B surface antigen levels of 3,000 international units per milliliter or less. The positive regulatory decision is based on the B-Well late-stage studies, in which 19% of patients who received Hibsago showed undetectable virus DNA and protein after 24 weeks of stopping all hepatitis B treatment, versus less than 1% functional cure rate after one year of treatment with the current standard of care. GSK said the injection has an "acceptable" safety and tolerability profile in B-Well, consistent with other studies. The London-listed pharmaceutical company expects additional regulatory decisions for Hibsago in other geographies in the coming months.