GSK (LSE:GSK) has received approval from the US Food and Drug Administration (FDA) for Hibsago (bepirovirsen), an antisense oligonucleotide treatment for certain adults with chronic hepatitis B virus (HBV) infection.
The approval covers adults receiving stable nucleos(t)ide analogue therapy who do not have cirrhosis. Hibsago is described as a first-in-class treatment designed to achieve a functional cure of chronic hepatitis B, an outcome characterised by sustained loss of hepatitis B surface antigen.
The FDA granted approval following a priority review, with the treatment having previously received Breakthrough Therapy Designation.
The regulatory decision was supported by results from GSK’s phase III B-Well clinical trial programme, which evaluated the efficacy and safety of bepirovirsen in adults with chronic hepatitis B.
According to the company, the trials demonstrated a functional cure rate of 19% across the overall study population. Among patients with lower baseline hepatitis B surface antigen (HBsAg) levels, the functional cure rate reached 26%.
GSK reported that functional cure rates among patients receiving existing standard-of-care treatment were close to zero, providing a comparison for the outcomes observed with bepirovirsen.
Hibsago is administered over a six-month treatment period and includes an option for self-administration. The treatment is intended for use alongside established nucleos(t)ide analogue therapy in the approved patient population.
The company also highlighted the role of quantitative HBsAg testing in identifying patients who may be suitable for treatment, based on their baseline surface antigen levels.
GSK described the safety profile observed in the clinical development programme as acceptable, with the phase III findings forming part of the evidence reviewed by the FDA.
The approval adds Hibsago to GSK’s portfolio of treatments targeting liver diseases, an area in which the company is developing therapies based on inflammation and immune-system biology.
Alongside chronic hepatitis B, GSK’s hepatology research includes programmes targeting metabolic dysfunction-associated steatohepatitis and alcohol-associated liver disease.
The company is also pursuing regulatory approvals for bepirovirsen in additional international markets, with decisions on existing submissions expected in the coming months.
The US authorisation establishes Hibsago as an approved treatment option for the specified chronic hepatitis B population. Its use in clinical practice will depend on patient eligibility, prescribing decisions and the treatment’s approved conditions of use.
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