BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - GSK plc (GSK, GSK.L) announced that Japan's Ministry of Health, Labour and Welfare has expanded the eligible population for RSV vaccine, Arexvy, to include adults aged 18 to 49 years at increased risk for RSV disease. GSK's RSV vaccine was previously approved in Japan for the prevention of RSV disease in all adults aged 60 years and older, and for adults aged 50-59 AIR for RSV disease.
The company said the approval was supported by data from a Phase IIIb trial demonstrating a non-inferior immune response in adults aged 18 to 49 years AIR for RSV disease compared to adults aged 60 years and above.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics, a subsidiary of Agenus Inc.
At last close, GSK plc shares were trading at 1,859.50 pence, down 0.16%.
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