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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在日本的獲批範圍擴大至50-59歲患有嚴重呼吸道合胞病毒疾病風險較高的成年人
美股SEC公告 ·  2024/11/22 06:25

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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宣佈日本批准Arexvy，這種生物-疫苗用於50-59歲面臨嚴重RSV疾病風險的成年人。該擴展將於2024年11月22日生效，使日本成爲第35個批准此生物-疫苗用於這一高風險人群的國家。Arexvy此前已於2023年9月在日本獲得60歲及以上成年人的批准。該批准基於一項全球第三期試驗，顯示在50-59歲高風險組中，其免疫原性與60歲及以上組相比並不遜色。安全性和反應性與初始第三期程序的結果一致。全球每年大約有6400萬名患者受到RSV影響，而由於某些潛在疾病，面臨嚴重後果（如肺炎和住院）的成年人風險更高。GSK的首席科學官Tony Wood強調了公司保護高風險個體免受嚴重RSV後果的承諾。這種生物-疫苗包含重組RSV糖蛋白F和GSK的專有AS01E佐劑。GSk繼續尋求在其他地區對Arexvy的監管批准。
GSk宣佈日本批准Arexvy，這種生物-疫苗用於50-59歲面臨嚴重RSV疾病風險的成年人。該擴展將於2024年11月22日生效，使日本成爲第35個批准此生物-疫苗用於這一高風險人群的國家。Arexvy此前已於2023年9月在日本獲得60歲及以上成年人的批准。該批准基於一項全球第三期試驗，顯示在50-59歲高風險組中，其免疫原性與60歲及以上組相比並不遜色。安全性和反應性與初始第三期程序的結果一致。全球每年大約有6400萬名患者受到RSV影響，而由於某些潛在疾病，面臨嚴重後果（如肺炎和住院）的成年人風險更高。GSK的首席科學官Tony Wood強調了公司保護高風險個體免受嚴重RSV後果的承諾。這種生物-疫苗包含重組RSV糖蛋白F和GSK的專有AS01E佐劑。GSk繼續尋求在其他地區對Arexvy的監管批准。
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