Date: 20-Oct-2026
Regulatory Authority: US Food and Drug Administration (USFDA)
Applicant: GlaxoSmithKline LLC
Application Number: NDA 221276
The US Food and Drug Administration (USFDA) approved Hibsago (bepirovirsen) injection, developed by GlaxoSmithKline LLC, in combination with existing antiviral therapy for the treatment of chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.
Key Approval Details
Hibsago is indicated for adults with chronic HBV infection who have received nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy for at least six months, have suppressed HBV DNA levels, and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test.
Bepirovirsen is an antisense oligonucleotide that targets viral genetic material to reduce HBV DNA and hepatitis B surface antigen levels. This treatment offers a new therapeutic approach for eligible patients who currently rely on long-term antiviral therapy.
Clinical and Regulatory Significance
Hibsago is the first USFDA-approved antisense oligonucleotide for chronic hepatitis B, representing an important development in the treatment of this chronic viral infection. In clinical trials, some patients receiving Hibsago alongside standard antiviral therapy achieved sustained viral control after discontinuing all HBV treatment.
The FDA granted Hibsago Fast Track and Breakthrough Therapy designations, along with Priority Review. The approval also includes postmarketing study requirements and enhanced pharmacovigilance measures to monitor important safety risks, including hepatic flare and thrombocytopenia.
Source:
USFDA Letter https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/221276Orig1s000Ltr.pdf
Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/221276Orig1s000lbl.pdf