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6-K: Arexvy Approval Expanded to Adults Aged 50-59 at Increased Risk of Severe Rsv Disease in Japan

6-K: Arexvy Approval Expanded to Adults Aged 50-59 at Increased Risk of Severe Rsv Disease in Japan

6-K：Arexvy在日本的获批范围扩大至50-59岁患有严重呼吸道合胞病毒疾病风险较高的成年人
美股SEC公告 ·  11/22 09:25

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GSK announced Japan's approval of Arexvy, its RSV vaccine, for adults aged 50-59 at increased risk of severe RSV disease. This expansion, effective November 22, 2024, makes Japan the 35th country to approve the vaccine for this at-risk population. Arexvy was previously approved in Japan for adults 60 and over in September 2023.The approval was based on a global phase III trial showing non-inferior immunogenicity in the 50-59 at-risk group compared to those 60 and older. Safety and reactogenicity were consistent with results from the initial phase III program. RSV affects an estimated 64 million people globally annually, with adults at increased risk due to certain underlying conditions facing severe outcomes like pneumonia and hospitalization.GSK's Chief Scientific Officer, Tony Wood, emphasized the company's commitment to protecting at-risk individuals from severe RSV consequences. The vaccine contains recombinant RSV glycoprotein F and GSK's proprietary AS01E adjuvant. GSK continues to seek regulatory approvals for Arexvy in other geographies.
GSK announced Japan's approval of Arexvy, its RSV vaccine, for adults aged 50-59 at increased risk of severe RSV disease. This expansion, effective November 22, 2024, makes Japan the 35th country to approve the vaccine for this at-risk population. Arexvy was previously approved in Japan for adults 60 and over in September 2023.The approval was based on a global phase III trial showing non-inferior immunogenicity in the 50-59 at-risk group compared to those 60 and older. Safety and reactogenicity were consistent with results from the initial phase III program. RSV affects an estimated 64 million people globally annually, with adults at increased risk due to certain underlying conditions facing severe outcomes like pneumonia and hospitalization.GSK's Chief Scientific Officer, Tony Wood, emphasized the company's commitment to protecting at-risk individuals from severe RSV consequences. The vaccine contains recombinant RSV glycoprotein F and GSK's proprietary AS01E adjuvant. GSK continues to seek regulatory approvals for Arexvy in other geographies.
GSk宣布日本批准Arexvy，这种生物-疫苗用于50-59岁面临严重RSV疾病风险的成年人。该扩展将于2024年11月22日生效，使日本成为第35个批准此生物-疫苗用于这一高风险人群的国家。Arexvy此前已于2023年9月在日本获得60岁及以上成年人的批准。该批准基于一项全球第三期试验，显示在50-59岁高风险组中，其免疫原性与60岁及以上组相比并不逊色。安全性和反应性与初始第三期程序的结果一致。全球每年大约有6400万名患者受到RSV影响，而由于某些潜在疾病，面临严重后果（如肺炎和住院）的成年人风险更高。GSK的首席科学官Tony Wood强调了公司保护高风险个体免受严重RSV后果的承诺。这种生物-疫苗包含重组RSV糖蛋白F和GSK的专有AS01E佐剂。GSk继续寻求在其他地区对Arexvy的监管批准。
GSk宣布日本批准Arexvy，这种生物-疫苗用于50-59岁面临严重RSV疾病风险的成年人。该扩展将于2024年11月22日生效，使日本成为第35个批准此生物-疫苗用于这一高风险人群的国家。Arexvy此前已于2023年9月在日本获得60岁及以上成年人的批准。该批准基于一项全球第三期试验，显示在50-59岁高风险组中，其免疫原性与60岁及以上组相比并不逊色。安全性和反应性与初始第三期程序的结果一致。全球每年大约有6400万名患者受到RSV影响，而由于某些潜在疾病，面临严重后果（如肺炎和住院）的成年人风险更高。GSK的首席科学官Tony Wood强调了公司保护高风险个体免受严重RSV后果的承诺。这种生物-疫苗包含重组RSV糖蛋白F和GSK的专有AS01E佐剂。GSk继续寻求在其他地区对Arexvy的监管批准。
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