FDA approves GSK's Hibsago for chronic hepatitis B treatment

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Go back to FDA approves GSK's Hibsago for chronic hepatitis B treatment

Hibsago (bepirovirsen) Approved in the US for the Treatment of Chronic Hepatitis B (CHB)

October 20, 2026 7:58 PM EDT

Approval based on phase III data showing unprecedented functional cure rates compared to standard of care Six-month treatment with option of self-administration after first dose CHB affects approximately 1.7 million people in the US1

PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI... More