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6-K: New data for arexvy, gsk's respiratory syncytial virus vaccine, show potential to help protect a broader group of adults at increased risk for rsv disease

6-K: New data for arexvy, gsk's respiratory syncytial virus vaccine, show potential to help protect a broader group of adults at increased risk for rsv disease

6-K：GSK呼吸道合胞病毒疫苗Arexvy的新数据显示可能有助于保护更广泛的成年人群体RSV疾病的风险
美股SEC公告 ·  2024/10/24 18:53

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GSK announced new preliminary data showing Arexvy, its respiratory syncytial virus (RSV) vaccine, demonstrated robust immune response in adults aged 18-49 at increased risk for RSV disease. The phase IIIb trial revealed that a single dose in high-risk adults aged 18-49 produced immune responses non-inferior to those in adults aged 60+, potentially benefiting over 21 million at-risk adults in the US alone.The phase IIb trial showed that immunocompromised adults aged 18+ who received two doses achieved immune responses comparable to healthy adults aged 50+ after one dose. The safety profile remained consistent with previous phase III results, with common side effects including injection site pain, fatigue, myalgia, arthralgia, and headache, mostly mild and transient.Currently approved in over 50 countries for adults aged 60+ and in several regions for at-risk adults aged 50-59, GSK plans to submit the final data to the FDA and other regulators for potential label updates. The ongoing trials will continue collecting safety and immunogenicity data until 2025.
GSK announced new preliminary data showing Arexvy, its respiratory syncytial virus (RSV) vaccine, demonstrated robust immune response in adults aged 18-49 at increased risk for RSV disease. The phase IIIb trial revealed that a single dose in high-risk adults aged 18-49 produced immune responses non-inferior to those in adults aged 60+, potentially benefiting over 21 million at-risk adults in the US alone.The phase IIb trial showed that immunocompromised adults aged 18+ who received two doses achieved immune responses comparable to healthy adults aged 50+ after one dose. The safety profile remained consistent with previous phase III results, with common side effects including injection site pain, fatigue, myalgia, arthralgia, and headache, mostly mild and transient.Currently approved in over 50 countries for adults aged 60+ and in several regions for at-risk adults aged 50-59, GSK plans to submit the final data to the FDA and other regulators for potential label updates. The ongoing trials will continue collecting safety and immunogenicity data until 2025.
GSk宣布新的初步数据显示，Arexvy，其呼吸道合胞病毒（RSV）生物-疫苗在18-49岁面临RSV疾病高风险的成年人中展现了强大的免疫反应。IIIb期试验显示，在18-49岁高风险成年人中，单剂量产生的免疫反应不低于60岁以上成年人，可能使美国超过2100万面临风险的成年人受益。IIb期试验显示，18岁及以上免疫功能受损的成年人在接种两剂后，获得的免疫反应与接种一剂后的健康成年人（50岁及以上）相当。安全性概况与之前的III期结果一致，常见副作用包括注射部位疼痛、疲劳、肌肉疼痛、关节痛和头痛，大多为轻微和短暂。目前已在50多个国家获得批准，适用于60岁及以上成年人，并在多个地区适用于50-59岁面临风险的成年人，GSk计划将最终数据提交给FDA和其他监管机构以进行潜在标签更新。正在进行的试验将继续收集安全性和免疫原性数据，直到2025年。
GSk宣布新的初步数据显示，Arexvy，其呼吸道合胞病毒（RSV）生物-疫苗在18-49岁面临RSV疾病高风险的成年人中展现了强大的免疫反应。IIIb期试验显示，在18-49岁高风险成年人中，单剂量产生的免疫反应不低于60岁以上成年人，可能使美国超过2100万面临风险的成年人受益。IIb期试验显示，18岁及以上免疫功能受损的成年人在接种两剂后，获得的免疫反应与接种一剂后的健康成年人（50岁及以上）相当。安全性概况与之前的III期结果一致，常见副作用包括注射部位疼痛、疲劳、肌肉疼痛、关节痛和头痛，大多为轻微和短暂。目前已在50多个国家获得批准，适用于60岁及以上成年人，并在多个地区适用于50-59岁面临风险的成年人，GSk计划将最终数据提交给FDA和其他监管机构以进行潜在标签更新。正在进行的试验将继续收集安全性和免疫原性数据，直到2025年。
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