Shots:
- The EMA has accepted MAA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB)
- MAA was 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
- Both trials met their 1EP, showing 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
Related News: GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
