GSK's Hibsago wins US approval for chronic hepatitis B treatment

GSK announced Tuesday that the FDA approved its drug Hibsago for treating chronic hepatitis B in the US, offering a potential functional cure for eligible adult patients. The approval applies to adults without cirrhosis who have been on NRTI therapy for at least six months, with suppressed viral DNA and hepatitis B surface antigen levels at or below 3,000 international units per milliliter. Hibsago, or bepirovirsen, is a first-in-class antisense oligonucleotide granted accelerated approval and breakthrough therapy designation. Phase 3 B-WELL trials showed functional cure rates of 19% compared to standard therapy alone. GSK's chief scientific officer noted patients can achieve functional cure after six months of treatment, with self-administration possible after the first dose. GSK shares closed 0.7% higher in London.