Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)
Key takeaways
- Hibsago’s FDA approval marks a breakthrough in chronic hepatitis B treatment, offering a 19% functional cure rate after six months—far above the <1% seen with existing care.
- 19% functional cure rate
- <1% standard care cure rate
- 1.7 million U.S. CHB patients
What happened
The U.S. Food and Drug Administration approved Hibsago (bepirovirsen) for treating chronic hepatitis B in adults without cirrhosis who are on nucleos(t)ide analogue therapy and have low surface antigen levels. The approval follows Phase 3 B‑Well trials that showed a 19% functional cure rate after six months of treatment, compared with less than 1% with standard care. Ionis Pharmaceuticals licensed the drug to GSK, which led the development and filed the application.
Why it matters
Hibsago offers a first‑in‑class RNA‑targeted therapy that can achieve functional cures—meaning the virus is controlled without ongoing medication—in a disease that affects about 1.7 million U.S. patients. The 19% cure rate is a dramatic improvement over the <1% seen with current therapies, potentially reducing…
Short-term and longer-term
Short-term. Over the next few weeks, traders should watch for GSK’s earnings guidance and any updates on commercial rollout plans.
Longer-term. For investors, the approval signals a long‑term shift in the CHB treatment landscape.