FDA approves GSK’s Hibsago for chronic hepatitis B
- The U.S. Food and Drug Administration approved Hibsago (bepirovirsen), developed by GSK and licensed from Ionis Pharmaceuticals, for a defined group of adults with chronic hepatitis B.
- The B-Well trials showed a 19% functional cure rate among eligible participants receiving bepirovirsen plus existing antiviral therapy, compared with 0% in the placebo group receiving background treatment.
- Ionis is eligible for 10%–12% tiered royalties on net sales, alongside potential additional regulatory and sales milestone payments, as GSK advances the medicine internationally.
Ionis Pharmaceuticals (NASDAQ:IONS) said partner GSK (NYSE:GSK) received U.S. FDA approval for Hibsago, an RNA-targeted treatment for certain adults with chronic hepatitis B.
The approval covers adults without cirrhosis who have received antiviral therapy for at least six months, with suppressed viral DNA and qualifying hepatitis B surface antigen levels.
“We are pleased to see the FDA approval of Hibsago,” said Ionis CEO Brett Monia, citing the potential to improve treatment options for chronic hepatitis B.
Pooled Phase 3 B-Well data showed a 19% functional cure rate among 1,220 bepirovirsen recipients, compared with no functional cures among 614 control participants.
The response rate reached 26% among patients with baseline hepatitis B surface antigen levels of 1,000 IU/ml or lower, compared with 0% in controls.
Under its 2019 licensing agreement with GSK, Ionis is eligible for additional regulatory and sales milestones and tiered royalties of 10%–12% on net sales.
Hibsago is administered over six months alongside existing antiviral therapy, with self-administration possible after the first dose, while GSK pursues approvals in additional markets.
