GSK announces EMA accepted for review the MAA for use of bepirovirsen

GSK (GSK) 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. 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. 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.