GSK plc (LON:GSK, NYSE:GSK) has announced that the European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) for the use of bepirovirsen, an investigational antisense oligonucleotide (ASO), in the treatment of adults with chronic hepatitis B (CHB).
• Submission supported by statistically significant and clinically meaningful functional cure rates in pivotal PhIII B-Well trials.
• Nearly 3.2 million people in Europe live with chronic hepatitis B (CHB), a leading cause of liver cancer.[1]
Chronic hepatitis B remains a public health concern in Europe, with an estimated 3.2 million people living with CHB.1The current standard of care – nucleos(t)ide analogues – often requires lifelong therapy and the functional cure rates remain low, typically only 1%.[2] Functional cure occurs when the hepatitis B virus DNA and viral protein – hepatitis B surface antigen (HBsAg) – are undetectable in the blood for at least 24 weeks after stopping all treatment, indicative of the disease being controlled by the immune system without medication. It is estimated that ~56% of liver cancer cases globally are caused by CHB.[3]
The regulatory submission to EMA is based on positive results from the B-Well 1 and B-Well 2 Phase III trials. Both trials met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone. Results were statistically significant across all ranked endpoints, including in patients with baseline surface antigen (HBsAg) <=1000 IU/ml where an even greater effect was demonstrated. The trials demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies. These data will be presented at a congress and submitted for scientific peer-reviewed publication in 2026.
[1] European Centre for Disease Prevention and Control. World Hepatitis Day 2025: Hepatitis burden remains high across the EU/EEA. 28 July 2025. Available at : https://www.ecdc.europa.eu/en/news-events/world-hepatitis-day-2025 (last accessed February 2026).
[2] Slaets, L. et al. “Systematic review with meta-analysis: hepatitis B surface antigen decline and seroclearance in chronic hepatitis B patients on nucleos(t)ide analogues or pegylated interferon therapy” in GastroHep 2, 106-116 (2020)
[3] Maucort-Boulch, D., de Martel, C., Franceschi, S. and Plummer, M. (2018), Fraction and incidence of liver cancer attributable to hepatitis B and C viruses worldwide. Int. J. Cancer, 142: 2471-2477. Available at: https://doi.org/10.1002/ijc.31280 (last accessed March 2026)
