Shots:
- The Japanese MHLW has accepted the NDA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB)
- NDA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in pts from 29 countries for the treatment of CHB
- Trials showed statistically significant & clinically meaningful functional cure rate, with higher responses vs SoC alone across all ranked endpoints, incl. greater benefit in pts with lower baseline HBsAg levels; data to be presented in a future conference & submitted for publication in 2026
Ref: GSK | Image: GSK | Press Release
Related News: GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus
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