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Bepirovirsen granted SENKU designation in Japan for chronic hepatitis B: GSK
![Bepirovirsen granted SENKU designation in Japan for chronic hepatitis B: GSK Bepirovirsen granted SENKU designation in Japan for chronic hepatitis B: GSK](https://medicaldialogues.in/h-upload/2024/02/01/750x450_231367-gsk-50.webp)
London: GSK plc has 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. 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.
The designation is based on results from the phase IIb B-Clear and B-Sure trials 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.
CHB affects 257 million people worldwide, and nearly 1 million people in Japan. 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]). 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.
According to GSK, Bepirovirsen is the only 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.
Read also: GSK Nucala approved in Japan for treatment of adults with chronic rhinosinusitis with nasal polyps
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751