GSK announces Japanese MHLW granted SENKU designation for bepirovirsen

GSK announced that the Japanese Ministry of Health, Labour and Welfare, MHLW, has granted SENKU 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 Fast Track designation for bepirovirsen granted earlier this year.