Health · Pharma & Biotech · 2 hrs ago
FDA approves bepirovirsen for some adults with chronic hepatitis B
The FDA approved bepirovirsen as a potential functional cure for chronic hepatitis B. The drug, sold as Hibsago, is made by GSK and Ionis.
The approval covers adults without cirrhosis who are taking antiviral therapy.
Chronic hepatitis B is a long-term infection, and a functional cure means an important treatment outcome rather than a claim that the infection is fully eliminated.
The approval was based on findings from the B-Well 1 study.
It matters because it gives some people with chronic hepatitis B a new treatment option.
The FDA approval came earlier than expected, though no further details on access or next steps are provided.
The FDA approved bepirovirsen, marketed as Hibsago, for some adults with chronic hepatitis B.
The approval covers adults without cirrhosis who are taking antiviral therapy.
The drug is described as a potential functional cure.
The FDA’s approval was based on findings from the B-Well 1 study.
- Who
- The FDA approved bepirovirsen for some adults with chronic hepatitis B.
- What
- The drug, marketed as Hibsago, was approved as a potential functional cure. It is for patients without cirrhosis who are taking antiviral therapy.
- When
- Tuesday, October 20, 2026.
- Where
- Not stated.
- Why
- The FDA’s approval was based on findings from the B-Well 1 study.
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- Drug
- Bepirovirsen (Hibsago)
- Eligible patients
- Adults with chronic hepatitis B, without cirrhosis, taking antiviral therapy
- Approval date
- Tuesday, October 20, 2026
- Evidence cited
- Findings from the B-Well 1 study