GSK’s Arexvy approval expanded to adults aged 50-59 with increased risk of severe RSV disease

GSK announces that Japan’s Ministry of Health, Labour and Welfare 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.

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 programme in adults aged 60 and older.

 



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