EMA accepts GSK’s bepirovirsen filing in chronic hepatitis B

GSK said the European Medicines Agency has accepted its marketing authorisation application for bepirovirsen, an investigational antisense oligonucleotide for adults with chronic hepatitis B. The filing is backed by positive phase 3 B-Well 1 and B-Well 2 data in more than 1,800 participants across 29 countries, where bepirovirsen plus standard of care achieved statistically significant, clinically meaningful functional cure rates versus standard care alone. GSK has said bepirovirsen isn’t approved in any country yet, and the EMA acceptance marks the start of the agency’s formal review. (investing.com)

Why it matters: For clinicians following liver and infectious disease pipelines, this is an important regulatory step for a drug candidate that aims at a long-standing gap in hepatitis B care: finite treatment with a chance at functional cure. Current nucleos(t)ide analogue therapy often means lifelong treatment, and GSK says functional cure rates with today’s standard of care are typically around 1%. If approved, bepirovirsen could become a first-in-class option and may be especially relevant for patients with lower baseline HBsAg levels, a subgroup that showed stronger effects in prior development work and in ranked phase 3 analyses. (gsk.com)

What to watch: Next up are detailed phase 3 data presentations and publication in 2026, along with the EMA review timeline and other global regulatory decisions, including Japan, where GSK already said the drug has been accepted for review. (investing.com)