GSK’s Bepirovirsen granted SENKU designation in Japan for chronic hepatitis B

GSK announces that the Japanese Ministry of Health, Labour and Welfare has granted SENKU designation for bepirovirsen, an investigational antisense oligonucleotide for the treatment of chronic hepatitis B. SENKU designation is granted based on the level of innovation, severity of disease, and prominent efficacy. SENKU’s goal designation is to increase early patient access to innovative medicines through an expedited review process to treat serious conditions and fill an unmet medical need.

CHB affects approximately 257 million people worldwide, however current treatment options provide a functional cure rate of less than 2-8% for pegylated interferon and less than 1% for oral treatments. Functional cure occurs when the hepatitis B virus DNA and viral protein, hepatitis B surface antigen, are at levels low enough to be undetectable in the blood and can be controlled by the immune system without medication. Current therapies only suppress the virus and do not directly lower HBsAg, which is essential for functional cure.

Bepirovirsen is the only current single agent in phase III development that has shown the potential to achieve clinically meaningful functional cure response when combined with oral NAs. Bepirovirsen is also being investigated as a potential backbone therapy in future sequential regimens to pursue functional cure in a broader population of patients with CHB.

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Related Topics and Keywords

bepirovirsen, GSK, Hepatitis, hepatitis B, senku