FDA Approves GSK's Hibsago for Chronic Hepatitis B Treatment
The FDA has approved Hibsago (bepirovirsen) for chronic hepatitis B. In trials, 19% of patients reached functional cure after a six-month course.
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what happened
The US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for chronic hepatitis B, according to a GSK announcement distributed by Reuters. The approval covers adults without cirrhosis who have been on nucleos(t)ide analogue therapy for at least six months, have suppressed HBV DNA and HBsAg levels of 3000 IU/ml or less.
The drug is used alongside existing therapy. Phase III B-Well trial data showed a 19% functional cure rate, while standard care alone typically achieves below 1% after one year. The course lasts six months, and patients may self-administer after the first dose. GSK says it continues to file for approval in other markets, with decisions expected in the coming months.
why it matters
For markets, the news matters mainly for GSK and the hepatitis B treatment segment. The US approval opens access to a market where GSK says about 1.7 million people live with the disease, but the revenue effect will depend on pricing, insurance coverage and decisions from regulators in other countries.
market impact
GSK: a new US-approved drug may support the company's future revenue outlook
tags
instruments
sources
- REG - GSK PLC - US FDA approves Hibsago for chronic hepatitis B — Reuters, 21 October 2026 at 06:00 UTC
- GSK Says US FDA Approves Hibsago For Chronic Hepatitis B — Reuters, 21 October 2026 at 06:15 UTC
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