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GSK PLC on Friday said the European Medicines Agency has accepted for review its investigational chronic hepatitis B treatment, bepirovirsen. The EMA review of GSK’s investigational drug came the day after an analogous acceptance by Japan’s Ministry of Health. The marketing authorisation application submitted to Europe’s medicines regulator was based on the results from two phase 3 trials, B-Well 1 and B-Well 2, which GSK said demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure is defined as a loss of hepatitis B surface antigen and undetectable viral genetic code for at least 24 weeks after a finite course of treatment. ‘Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone...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’, GSK said. The results of the two phase 3 trials, involving over 1,800 patients in 29 countries, were released in early January. Further evaluations of the drug as a backbone therapy for treatment strategies aimed at a broader patient population are ongoing. Hepatitis B, a viral infection, can cause both acute and chronic liver diseases, and affects more than 250 million people worldwide causing about 1.1 million deaths each year, of which about 15,000 in Europe. Its chronic form accounts for about 56% of liver cancer cases, and 3.2 million people are estimated to be living with it in Europe. GSK shares were down 0.9% to 2,029.00 pence each on Friday morning in London. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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