share_log

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的新數據顯示可能有助於保護更廣泛的成年人群體RSV疾病的風險
美股SEC公告 ·  2024/10/24 18:53

Moomoo AI 已提取核心訊息

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宣佈新的初步數據顯示，Arexvy，其呼吸道合胞病毒（RSV）生物-疫苗在18-49歲面臨RSV疾病高風險的成年人中展現了強大的免疫反應。IIIb期試驗顯示，在18-49歲高風險成年人中，單劑量產生的免疫反應不低於60歲以上成年人，可能使美國超過2100萬面臨風險的成年人受益。IIb期試驗顯示，18歲及以上免疫功能受損的成年人在接種兩劑後，獲得的免疫反應與接種一劑後的健康成年人（50歲及以上）相當。安全性概況與之前的III期結果一致，常見副作用包括注射部位疼痛、疲勞、肌肉疼痛、關節痛和頭痛，大多爲輕微和短暫。目前已在50多個國家獲得批准，適用於60歲及以上成年人，並在多個地區適用於50-59歲面臨風險的成年人，GSk計劃將最終數據提交給FDA和其他監管機構以進行潛在標籤更新。正在進行的試驗將繼續收集安全性和免疫原性數據，直到2025年。
GSk宣佈新的初步數據顯示，Arexvy，其呼吸道合胞病毒（RSV）生物-疫苗在18-49歲面臨RSV疾病高風險的成年人中展現了強大的免疫反應。IIIb期試驗顯示，在18-49歲高風險成年人中，單劑量產生的免疫反應不低於60歲以上成年人，可能使美國超過2100萬面臨風險的成年人受益。IIb期試驗顯示，18歲及以上免疫功能受損的成年人在接種兩劑後，獲得的免疫反應與接種一劑後的健康成年人（50歲及以上）相當。安全性概況與之前的III期結果一致，常見副作用包括注射部位疼痛、疲勞、肌肉疼痛、關節痛和頭痛，大多爲輕微和短暫。目前已在50多個國家獲得批准，適用於60歲及以上成年人，並在多個地區適用於50-59歲面臨風險的成年人，GSk計劃將最終數據提交給FDA和其他監管機構以進行潛在標籤更新。正在進行的試驗將繼續收集安全性和免疫原性數據，直到2025年。
有用
沒用

該公告為獨立文件：

獨立文件1  查看翻譯

声明：本內容僅用作提供資訊及教育之目的，不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    相關股票 相關股票
    代碼 迷你走勢 最新價
    施貴寶
    BMY
    -- 60.020
    默沙東
    MRK
    -- 89.230
    賽諾菲安萬特
    SNY
    -- 55.820
    阿斯利康
    AZN
    -- 73.790
    艾伯維公司
    ABBV
    -- 205.290
    解鎖完整榜單
    重估中國資產
    繼中國開創性的DeepSeek技術推出之後，華爾街大行重估對中國市場的投資前景。
    熱門討論
    FOMC維持利率但不確定性高企：美股後市走向如何？
    🎙️討論 1. 美聯儲強調政策路徑存在「高度不確定性」，你更關注利率預期變化還是經濟數據對市場的短期影響？ 2. 若核心通脹維持高位，哪類板塊更具交易機會——防禦型股票還是科技成長股？ 展开
    聯邦公開市場委員會新聞發佈會，2025年3月19日