GSK hepatitis B drug secures FDA priority review

(Sharecast News) - Pharmaceutical giant GSK said on Tuesday that the US Food and Drug Administration had accepted its new drug application for bepirovirsen for priority review, with the drug being assessed as a potential treatment for adults with chronic hepatitis B.

GSK said the therapy had also been granted breakthrough therapy designation, which follows its receipt of fast‑track status in February 2024, intended to speed reviews for treatments addressing serious unmet need.

The FTSE 100-listed firm stated the submission and breakthrough designation were backed by positive Phase III B‑Well 1 and B‑Well 2 results, where bepirovirsen delivered "statistically significant and clinically meaningful" functional‑cure rates and showed an "acceptable safety profile".

GSK noted that chronic hepatitis B affects more than 250m people worldwide and around 1.7m in the US, with current standard therapies often requiring lifelong treatment and delivering functional‑cure rates of roughly 1%.

As of 1020 BST, GSK shares were down 0.74% at 2,001p.

Reporting by Iain Gilbert at Sharecast.com

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