> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves GSK’s Hibsago for Chronic Hepatitis B
- URL: https://www.fdaweb.com/fda-approves-gsks-hibsago-for-chronic-hepatitis-b/
- Published: 2026-10-20T21:44:36.000Z
- Updated: 2026-10-20T21:44:36.000Z
- Author: David McFarland
- Tags: Drugs

FDA has approved GlaxoSmithKline’s Hibsago (bepirovirsen) to treat chronic hepatitis B virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least six months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B virus (HBV) surface antigen (HBsAg) levels ≤3000 IU/ml, as determined by an FDA-authorized test. A company [statement](ttps://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-hepatitis-b-chb/) says the approval is based on Phase 3 data showing “unprecedented functional cure rates compared to standard of care.”

The application received FDA Priority Review and Breakthrough Therapy designation.

Bepirovirsen is described as an antisense oligonucleotide designed to recognize and inhibit the production of the genetic components of the hepatitis B virus that can lead to chronic disease.