Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)
Business Wire•20/10/2026•21:20 ET
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Key Highlights
- ➤Hibsago approved in U.S. for eligible adults with chronic hepatitis B
- ➤Phase 3 trials delivered 19% functional cure versus less than 1% standard care
- ➤Six-month treatment achieved 26% functional cure in patients with HBsAg ≤1000 IU/ml
- ➤Ionis eligible for 10-12% tiered royalties on Hibsago net sales
- ➤Hibsago carries boxed warnings for hepatic flares and potentially life-threatening thrombocytopenia
Expert Statements
Brett P. Monia, Chief executive officer of Ionis Pharmaceuticals
“About 1.7 million people in the U.S are living with chronic hepatitis B, and yet treatment options have been historically limited and the vast majority of people living with the chronic infection require lifetime care without achieving meaningful functional cure”
Brett P. Monia, Chief executive officer of Ionis Pharmaceuticals
“We are pleased to see the FDA approval of Hibsago, which adds to a growing portfolio of transformative medicines discovered and developed by Ionis that address serious diseases, including many that previously had limited or no available treatment options. We believe Hibsago will bring new hope to people living with chronic hepatitis B, offering the potential to achieve unprecedented functional cure rates after a six-month treatment course.”
Norah Terrault, Chief of Gastroenterology & Hepatology, USC Keck Medical Centre
“This is the start of a new era in treating people living with CHB”
Norah Terrault, Chief of Gastroenterology & Hepatology, USC Keck Medical Centre
“Bepirovirsen offers patients the potential to achieve functional cure after a short period of treatment, a long-standing goal for patients and physicians alike.”
Chari Cohen, President of Hepatitis B Foundation
“CHB is a major public health challenge, affecting millions of people in the U.S. and accounting for approximately 56% of all global liver cancer cases”
Chari Cohen, President of Hepatitis B Foundation
“Today marks significant progress towards our aim of transforming the way CHB is managed with improvements in screening, diagnosis, and the availability of innovative treatment options for our community.”
Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)
– Approval based on Phase 3 data showing unprecedented functional cure rates compared to standard of care –
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