Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)
The FDA approved Hibsago (bepirovirsen), Ionis' partnered first-in-class antisense therapy for chronic hepatitis B, granted under priority review and Breakthrough Therapy Designation. Phase 3 B-Well data showed a 19% functional cure rate versus less than 1% for standard of care, rising to 26% in patients with HBsAg ≤1000 IU/ml. GSK licensed the drug from Ionis in 2019, and Ionis receives tiered royalties of 10-12% on net sales plus regulatory and sales milestones. The approval opens a U.S.
Key figures
- Drug Name
- Hibsago (bepirovirsen)
- Phase Of Trial
- Phase 3
- Royalty rate
- 10-12% of net sales
- Us chb patients
- 1.7 million
- Functional cure rate overall
- 19%
- Functional cure rate hbsag 1000
- 26%
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