Ionis Pharmaceuticals announced that its partner, GSK, has received U.S. Food and Drug Administration (FDA) approval for HIBSAGO™ (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection. Bepirovirsen, a first-in-class RNA-targeted medicine, was originally discovered and developed by Ionis before being licensed to GSK.
Key Details
- Drug Approval: The FDA approved HIBSAGO™ (bepirovirsen) on October 20, 2026, for adult patients with chronic hepatitis B. The approval was granted under FDA priority review and Breakthrough Therapy Designation.
- Clinical Efficacy: Approval was supported by Phase 3 B-Well trials, which demonstrated a 19% functional cure rate in the specified patient population, compared to a less than 1% cure rate for the current standard of care.
- Financial Impact: Under its 2019 licensing agreement with GSK, Ionis is eligible to receive additional regulatory and sales milestone payments, as well as tiered royalties of 10-12% on net sales of HIBSAGO™.