Shots:
- The US FDA has accepted NDA & granted priority review as well as BTD to GSK‘s bepirovirsen for the treatment of adults with chronic hepatitis B (CHB)
- NDA & designation were supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml across 29 countries
- In the trials, bepirovirsen showed improved 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
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