FDA approves GSK's Hibsago (bepirovirsen) for chronic hepatitis B
On 20 October 2026 the U.S. Food and Drug Administration granted approval to GSK’s antisense oligonucleotide Hibsago (bepirovirsen) for adult patients with chronic hepatitis B who have no cirrhosis and meet specific viral‑load criteria. The drug received priority review and Breakthrough Therapy Designation and is licensed from Ionis Pharmaceuticals. Phase‑III trials showed a 19% functional‑cure rate after a six‑month course, far above the less‑than‑1% rate of standard care.
Why it matters
The company says the new therapy could expand GSK’s hepatitis‑B portfolio and generate additional revenue streams. Analysts note that a functional‑cure rate of 19% may drive significant market uptake among the roughly 1.7 million U.S. patients with chronic hepatitis B.
Key facts
- 1The FDA approved Hibsago (bepirovirsen) on 20 October 2026. marketscreener.com
- 2The indication is for adult chronic hepatitis B patients without cirrhosis who have been on nucleos(t)ide analogue therapy for ≥6 months, have suppressed HBV DNA and HBsAg ≤3,000 IU/mL. marketscreener.com
- 3Phase‑III B‑Well trials reported a 19% functional‑cure rate (233 of 1,220) versus 0% in the placebo group. marketscreener.com
- 4The approval was granted under priority review and Breakthrough Therapy Designation. marketscreener.com
- 5GSK licensed bepirovirsen from Ionis Pharmaceuticals. marketscreener.com
- 6GSK shares closed up 0.7% at 1,868.50 pence in London after the announcement. marketscreener.com
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.