FDA Approves Hibsago as First Functional Cure for Hepatitis B
The FDA approved bepirovirsen (Hibsago) from GSK and Ionis on November 11, 2026. This drug is seen as a potential functional cure for chronic hepatitis B infections. In Phase 3 trials, 19% of participants achieved undetectable virus levels after six months of treatment.
The U.S. Food and Drug Administration (FDA) has approved bepirovirsen, marketed as Hibsago. This marks the first drug that may offer a functional cure for chronic hepatitis B. The announcement was made on November 11, 2026, following a collaboration between GSK and Ionis Pharmaceuticals. The approval addresses the critical need for effective treatments for chronic hepatitis B, which affects about 1.7 million people in the U.S. and approximately 240 million worldwide. Hibsago is intended to be used alongside standard antiviral therapies and has shown promising results in clinical trials, with 19% of participants reaching undetectable levels of the virus after six months of treatment.
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