GSK (GSK) announced that Japan’s Ministry of Health, Labour and Welfare, MHLW, has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus vaccine to include adults aged 18-49 at increased risk of severe RSV disease. Arexvy was the first vaccine approved in Japan for adults aged 60 years and older for the prevention of RSV disease, and for those aged 50 years and older at increased risk for severe RSV disease. This regulatory submission is supported by positive results from phase IIIb trial NCT06389487 which showed a non-inferior immune response in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions, to that observed in adults aged 60 and above.
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