April 2026- GSK plc announced that the US Food and Drug Administration has accepted for priority review its New Drug Application for bepirovirsen, an investigational antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB).

Bepirovirsen has also received Breakthrough Therapy Designation, given to investigational medicines that show potential for substantial improvement over existing therapies. This follows the Fast Track Designation granted by the FDA in February 2024, aimed at speeding up the review of treatments for serious conditions with unmet medical needs.

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Chronic hepatitis B affects more than 250 million people globally and around 1.7 million people in the United States. Current standard treatment often requires lifelong therapy, while functional cure rates remain low at around 1%. Functional cure means hepatitis B virus DNA and hepatitis B surface antigen remain undetectable in the blood for at least 24 weeks after stopping treatment.

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The regulatory submission is supported by positive Phase III B-Well 1 and B-Well 2 trial results, where bepirovirsen showed statistically significant and clinically meaningful functional cure rates compared to standard of care alone. The medicine also demonstrated an acceptable safety and tolerability profile consistent with previous studies.

The FDA has set 26 October 2026 as the Prescription Drug User Fee Act goal date for its decision.