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SENKU Designation for Bepirovirsen in Japan
SENKU Designation for Bepirovirsen in Japan.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 28 August 2024, London UK\n \nBepirovirsen granted SENKU designation in Japan for chronic hepatitis B\n \n· Designation expedites review of bepirovirsen as a potential treatment for people living with chronic hepatitis B (CHB)\n· Designation based on strength of data from the B-Clear and B-Sure trials and need for innovative medicines to achieve functional cure\n· SENKU follows US FDA Fast Track designation earlier this year\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SENKU (formerly known as SAKIGAKE) designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). SENKU designation is granted based on the level of innovation, severity of disease, and prominent efficacy. The goal of SENKU 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.\n \nThe designation is based on results from the phase IIb B-Clear and B-Sure trials1,2 which evaluated the efficacy, safety and durability of response of bepirovirsen in people with CHB. A confirmatory phase III programme, B-Well, is ongoing. This is the second regulatory designation in 2024 for bepirovirsen, following the US Food and Drug Administration (FDA) Fast Track designation for bepirovirsen granted earlier this year. Further information is available at: https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b.\n \nCHB affects 257 million people worldwide, and nearly 1 million people in Japan.3 Current treatment options provide a functional cure rate of less than 2-8% for pegylated interferon (PegIFN) and less than 1% for oral treatments (nucleoside/nucleotide analogues [NAs]).4 Functional cure occurs when the hepatitis B virus DNA and viral protein, hepatitis B surface antigen (HBsAg), 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.\n \nBepirovirsen is the only single agent in phase III dev...