The US Food and Drug Administration (FDA) has approved Hibsago, a new hepatitis B medicine developed by British pharmaceutical company GSK. The treatment may allow some patients with chronic hepatitis B to maintain control of the virus after stopping antiviral therapy.

The drug, known by its generic name bepirovirsen, is the first antisense oligonucleotide approved by the FDA to treat chronic hepatitis B. It is designed to reduce viral genetic material and proteins, including hepatitis B surface antigen (HBsAg), while helping the immune system regain control of the infection.

Clinical Trials Show Potential for Sustained Viral Control

The approval follows results from the global Phase III B-Well 1 and B-Well 2 clinical trials, conducted across 29 countries.

According to the FDA, 19% of patients who received Hibsago maintained viral control and had undetectable hepatitis B surface antigen 24 weeks after stopping all treatment. In comparison, none of the patients in the placebo group met this outcome.

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The treatment is approved for certain adults with chronic hepatitis B who do not have cirrhosis and meet specific criteria for existing antiviral treatment and viral markers. Hibsago is administered by injection alongside standard antiviral therapy. Patients must continue their existing medicine for a period after their final Hibsago injection, and only eligible patients may later stop treatment under medical supervision.

Chronic Hepatitis B Remains a Global Health Challenge

Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic infection can persist for years and may lead to cirrhosis, liver failure and liver cancer.

More than 240 million people worldwide live with chronic hepatitis B, according to figures cited in the supplied press release. The disease causes approximately 1.1 million deaths each year and remains a leading cause of liver cancer globally.

Existing antiviral medicines can suppress the virus but often require long-term treatment. A functional cure means the virus remains under control, with key viral markers undetectable, after treatment ends. It does not necessarily mean the virus has been completely eliminated from the body.

Approval Follows Earlier Clearance in Japan

Hibsago was approved in Japan in August 2026, before receiving US regulatory approval. GSK has also reported that the medicine was under review in China and Europe.

The FDA approval marks a new treatment option for eligible adults with chronic hepatitis B. However, the medicine carries important safety warnings, including risks of serious liver reactions and low platelet counts. Patients require medical assessment and regular monitoring during treatment. <Cite refs={[“turn879851search0”]}/>