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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 22:25

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Japan's Ministry of Health, Labour and Welfare has approved GSK's Arexvy vaccine for adults aged 50-59 at increased risk of severe RSV disease, expanding its previous approval for those 60 and older. This makes Japan the 35th country to approve the vaccine for this at-risk population group, joining markets including the US.The approval was supported by global phase III trial results demonstrating non-inferior immunogenicity in adults aged 50-59 at increased risk compared to those 60 and older. The safety profile remained consistent with earlier findings in older adults. RSV affects an estimated 64 million people globally annually and can lead to severe outcomes like pneumonia and hospitalization, particularly in those with underlying conditions.The vaccine contains recombinant RSV glycoprotein F with GSK's AS01E adjuvant system. This expansion reflects GSK's commitment to protecting vulnerable populations from RSV disease, which can exacerbate conditions including COPD, asthma, and chronic heart failure.
Japan's Ministry of Health, Labour and Welfare has approved GSK's Arexvy vaccine for adults aged 50-59 at increased risk of severe RSV disease, expanding its previous approval for those 60 and older. This makes Japan the 35th country to approve the vaccine for this at-risk population group, joining markets including the US.The approval was supported by global phase III trial results demonstrating non-inferior immunogenicity in adults aged 50-59 at increased risk compared to those 60 and older. The safety profile remained consistent with earlier findings in older adults. RSV affects an estimated 64 million people globally annually and can lead to severe outcomes like pneumonia and hospitalization, particularly in those with underlying conditions.The vaccine contains recombinant RSV glycoprotein F with GSK's AS01E adjuvant system. This expansion reflects GSK's commitment to protecting vulnerable populations from RSV disease, which can exacerbate conditions including COPD, asthma, and chronic heart failure.
日本衛生、勞動和福利部已批准GSK的Arexvy生物-疫苗，適用於年齡在50至59歲且嚴重RSV疾病風險增加的成人，此次批准擴展了之前對60歲及以上人群的批准。這使日本成爲第35個批准該生物-疫苗的國家，加入包括美國在內的市場。該批准得到了全球第三階段試驗結果的支持，顯示在增加風險的50至59歲成人中，與60歲及以上人群相比，免疫原性無劣效。安全性特徵與早期在老年人中的發現保持一致。RSV每年在全球大約影響6400萬人，可能導致肺炎和住院等嚴重後果，尤其是在有基礎疾病的人群中。該生物-疫苗含有重組RSV糖蛋白F以及GSK的AS01E佐劑系統。這一擴展反映了GSK對保護易受傷害人群免受RSV疾病影響的承諾，該疾病可能加重包括COPD、哮喘和慢性心力衰竭在內的病症。
日本衛生、勞動和福利部已批准GSK的Arexvy生物-疫苗，適用於年齡在50至59歲且嚴重RSV疾病風險增加的成人，此次批准擴展了之前對60歲及以上人群的批准。這使日本成爲第35個批准該生物-疫苗的國家，加入包括美國在內的市場。該批准得到了全球第三階段試驗結果的支持，顯示在增加風險的50至59歲成人中，與60歲及以上人群相比，免疫原性無劣效。安全性特徵與早期在老年人中的發現保持一致。RSV每年在全球大約影響6400萬人，可能導致肺炎和住院等嚴重後果，尤其是在有基礎疾病的人群中。該生物-疫苗含有重組RSV糖蛋白F以及GSK的AS01E佐劑系統。這一擴展反映了GSK對保護易受傷害人群免受RSV疾病影響的承諾，該疾病可能加重包括COPD、哮喘和慢性心力衰竭在內的病症。
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