GSK and Ionis receive FDA nod for Hibsago, a potential functional cure for chronic hepatitis B

The U.S. Food and Drug Administration has cleared Hibsago, a collaborative product of GSK and Ionis, as the first therapy of its kind aimed at chronic hepatitis B.

The medicine is to be added to standard antiviral regimens for adult patients who have not progressed to cirrhosis, have been on antivirals for at least six months, show suppressed viral load and low levels of a protein that signals active infection.

Administration involves periodic injections over a six‑month period; the initial dose is given in a clinical setting while later doses can be self‑administered, according to the companies.

Pricing has not been disclosed, with GSK stating it will be set after completing reimbursement talks. The approval aligns with GSK’s target of achieving £40 billion in annual revenue by 2031.