GSK and Ionis receive FDA nod for hepatitis B therapy promising functional cure

GSK and Ionis announced that the U.S. Food and Drug Administration has approved their hepatitis B drug bepirovirsen, now marketed as Hibsago.

The therapy is intended for chronic hepatitis B patients and seeks to achieve a functional cure, allowing the virus to be controlled without continuous medication.

The early approval sets the product on a path toward blockbuster potential, though additional data will be required to confirm its long‑term efficacy and safety.

Industry observers view the decision as a major milestone for GSK's infectious‑disease portfolio and may reshape the competitive landscape for hepatitis B treatments.