FDA approves GSK's Hibsago for chronic hepatitis B treatment in US
The FDA has approved GSK's Hibsago (bepirovirsen) for chronic hepatitis B in adults without cirrhosis, according to TradingView citing the company.
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what happened
The US Food and Drug Administration has approved GSK's Hibsago (bepirovirsen) for chronic hepatitis B infection. The drug is used alongside nucleos(t)ide analogue therapy in adults without cirrhosis who have taken that treatment for at least six months, with suppressed HBV DNA and HBsAg levels up to 3,000 IU/mL.
The approval rests on data from the phase III B-Well trials, in which 19% of patients achieved functional cure. The company said standard care achieves less than 1% functional cure after one year. The drug received Priority Review and Breakthrough Therapy Designation.
why it matters
The news matters for GSK shares as confirmation of its hepatitis B pipeline. Ionis, which licensed the drug to GSK, is also tied to the outcome of this technology. Decisions from regulators in other regions are expected in the coming months.
market impact
GSK: US approval strengthens the company's pipeline; Ionis: benefits from the licensing agreement
tags
instruments
sources
- Hibsago (bepirovirsen) Approved in the US for the Treatment of Chronic Hepatitis B (CHB) — TradingView, 20 October 2026 at 23:58 UTC
- Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB) — TradingView, 21 October 2026 at 01:20 UTC
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