20th Jun 2025 08:27
(Alliance News) - GSK PLC on Friday announced that Japan has accepted a regulatory application to expand the use of its respiratory syncytial virus [RSV] vaccine Arexvy.
The London-based pharmaceutical company said Japan's Ministry of Health, Labour & Welfare accepted the regulatory application to expand use of the vaccine in adults aged 18 to 49 who are at increased risk of severe RSV.
The application is supported by positive results from a phase 3B data which showed a non-inferior immune response in adults aged 18 to 49 at increased risk for RSV-lower respiratory tract disease due to some underlying medical conditions, to that observed in adults aged 60 and over.
GSK said it is the first company to seek regulatory approval for the vaccine for 18-49 year olds at increased risk of RSV disease in Japan.
GSK shares were flat at 1,435.00 pence each on Friday morning in London, giving it a market capitalisation of GBP58.74 billion.
By Tom Budszus, Alliance News slot editor
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