FDA approves bepirovirsen, a new kind of treatment for chronic hepatitis B
Oct. 21, 2026 — The Food and Drug Administration approved Hibsago (bepirovirsen), an injection used with existing antiviral therapy, for certain adults with chronic hepatitis B who do not have cirrhosis, the agency said Oct. 20. It is the first antisense oligonucleotide approved for the disease. In two trials, 24% of patients who received it met the requirements to stop their existing medicine, compared with none on placebo, and 19% still had the virus under control 24 weeks after stopping all treatment. The drug carries a boxed warning for serious liver reactions and low platelet counts.
The wall: Longer-term outcomes were not included in the announcement.
Tier: Confirmed (based on the FDA's announcement)
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