GSK announces Japan’s MHLW approved application to extend indication of Arexvy

GSK (GSK) announced that Japan’s Ministry of Health, Labour and Welfare, MHLW, has approved a regulatory application to extend the indication of Arexvy for the prevention of RSV disease to include adults aged 50-59 at increased risk. Since September 2023, GSK’s RSV vaccine has been approved in Japan for adults aged 60 and over for the prevention of RSV disease. Tony Wood, Chief Scientific Officer at GSK, said: “This approval reflects our ambition to protect people at increased risk from the severe consequences of RSV infection. Adults aged 50-59 with certain underlying medical conditions can face debilitating consequences from RSV, so we are pleased to offer those in Japan a vaccine for the first time.” This regulatory expansion was supported by results from a global phase III trial that showed non-inferior immunogenicity in adults aged 50-59 at increased risk of RSV lower respiratory tract disease compared to those aged 60 and older. Safety and reactogenicity in the 50-59 at increased risk population were consistent with results from the initial phase III program in adults aged 60 and older.