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Bepirovirsen accepted for review by the EMA
GSK plc announced that the European Medicines Agency has accepted for review its marketing authorisation application for bepirovirsen, an investigational treatment for chronic hepatitis B. This submission is supported by positive results from the pivotal Phase III B-Well trials, which demonstrated statistically significant and clinically meaningful functional cure rates for bepirovirsen in combination with standard of care, compared to standard of care alone. Chronic hepatitis B affects an estimated 3.2 million people in Europe, and current treatments have low functional cure rates, typically around 1%. Disclaimer*
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 27th March 2026, London UK\n \nBepirovirsen accepted for review by the European Medicines Agency as a potential first-in-class treatment for chronic hepatitis B\n \n• Submission supported by statistically significant and clinically meaningful functional cure rates in pivotal PhIII B-Well trials.\n• Nearly 3.2 million people in Europe live with chronic hepatitis B (CHB), a leading cause of liver cancer.[1]\n \nGSK plc (LSE/NYSE: GSK) today 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).\n \nChronic 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]\n \nThe 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.\n \nAbout chronic hepatitis B\nHepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic hepatitis B occurs when the immune sy...