Japan accepts GSK Arexvy regulatory application to prevent RSV disease in adults aged 50-59 at increased risk
London: GSK plc has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a regulatory application to extend the indication of GSK’s respiratory syncytial virus (RSV) vaccine (recombinant adjuvanted) for the prevention of RSV disease in adults aged 50-59 at increased risk.
This regulatory submission follows Japan’s approval of GSK’s vaccine for the prevention of RSV disease in adults from the age of 60 years, and the recent announcement of the positive results of a phase III trial [NCT05590403] evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV lower respiratory tract disease (LRTD) due to certain underlying medical conditions.
Read also: GSK RSV shot Arexvy approved in Britain for adults aged 60 years and older
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