Health

FDA approves Hibsago, the first drug with the potential to cure chronic hepatitis B

The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen), GSK's first-in-class antisense therapy for chronic hepatitis B — the first treatment offering patients the potential to achieve functional cure after a six-month course, the company announced on October 20.

The approval was granted under FDA Priority Review and Breakthrough Therapy Designation. It covers adults without cirrhosis who have been on antiviral therapy for at least six months, with suppressed viral DNA and surface antigen levels at or below 3,000 IU/ml. The drug offers the option of self-administration after the first dose.

In the phase 3 B-WELL trials, six months of treatment achieved functional cure — virus undetectable for at least 24 weeks after stopping all medication — in 19% of patients, compared with less than 1% on current standard of care alone. Chronic hepatitis B affects approximately 1.7 million people in the United States, most of whom today remain on treatment indefinitely.

"For the first time, with Hibsago, U.S. patients have the potential to achieve functional cure after a six-month treatment course," said GSK chief scientific officer Tony Wood.

Sources: GSK (Oct 20, 2026); Healio (Oct 21, 2026).

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