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6-K: Depemokimab Accepted for Review by the European Medicines Agency for Use in Asthma with Type 2 Inflammation and Crswnp

6-K: Depemokimab Accepted for Review by the European Medicines Agency for Use in Asthma with Type 2 Inflammation and Crswnp

6-K:歐洲藥品管理局已接受Depemokimab的審查,用於治療伴有2型炎症和CRSwNP的哮喘
美股SEC公告 ·  01/28 11:09

牛牛AI助理已提取核心訊息

GSK announced that the European Medicines Agency has accepted the Marketing Authorization Application for depemokimab in two indications: asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP). If approved, depemokimab will become the first ultra-long-acting biologic offering 6-month dosing intervals.The submission is supported by positive results from the SWIFT trials in asthma patients and ANCHOR trials in CRSwNP patients. The SWIFT studies demonstrated reduced exacerbation and hospitalization rates in asthma patients, while ANCHOR trials showed significant reduction in nasal polyp size and obstruction compared to placebo.Depemokimab targets interleukin-5 (IL-5), a key driver of type 2 inflammation, which affects the majority of difficult-to-treat asthma patients and up to 80% of CRSwNP patients. The treatment could benefit over 42 million asthma patients in Europe, where the condition has an estimated annual societal cost of 46 billion euros, and up to 4% of the general population affected by CRSwNP.
GSK announced that the European Medicines Agency has accepted the Marketing Authorization Application for depemokimab in two indications: asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP). If approved, depemokimab will become the first ultra-long-acting biologic offering 6-month dosing intervals.The submission is supported by positive results from the SWIFT trials in asthma patients and ANCHOR trials in CRSwNP patients. The SWIFT studies demonstrated reduced exacerbation and hospitalization rates in asthma patients, while ANCHOR trials showed significant reduction in nasal polyp size and obstruction compared to placebo.Depemokimab targets interleukin-5 (IL-5), a key driver of type 2 inflammation, which affects the majority of difficult-to-treat asthma patients and up to 80% of CRSwNP patients. The treatment could benefit over 42 million asthma patients in Europe, where the condition has an estimated annual societal cost of 46 billion euros, and up to 4% of the general population affected by CRSwNP.
GSK宣佈,歐洲藥品管理局已接受depemokimab的市場授權申請,適用於兩個適應症:伴有2型炎症的哮喘及伴有鼻息肉的慢性鼻竇炎(CRSwNP)。如果獲得批准,depemokimab將成爲首個提供6個月給藥間隔的超長效生物製劑。該申請得到了SWIFT試驗在哮喘患者和ANCHOR試驗在CRSwNP患者中的積極結果支持。SWIFT研究顯示,哮喘患者的急性發作和住院率降低,而ANCHOR試驗顯示,鼻息肉大小和阻塞程度相比於安慰劑有顯著減少。Depemokimab靶向白細胞介素-5(IL-5),這是2型炎症的主要驅動因素,影響了大多數難以治療的哮喘患者和多達80%的CRSwNP患者。這種治療可使超過4200萬名歐洲的哮喘患者受益,而哮喘在該地區的年社會成本預計爲460億歐元,且最多影響4%的普通人群。
GSK宣佈,歐洲藥品管理局已接受depemokimab的市場授權申請,適用於兩個適應症:伴有2型炎症的哮喘及伴有鼻息肉的慢性鼻竇炎(CRSwNP)。如果獲得批准,depemokimab將成爲首個提供6個月給藥間隔的超長效生物製劑。該申請得到了SWIFT試驗在哮喘患者和ANCHOR試驗在CRSwNP患者中的積極結果支持。SWIFT研究顯示,哮喘患者的急性發作和住院率降低,而ANCHOR試驗顯示,鼻息肉大小和阻塞程度相比於安慰劑有顯著減少。Depemokimab靶向白細胞介素-5(IL-5),這是2型炎症的主要驅動因素,影響了大多數難以治療的哮喘患者和多達80%的CRSwNP患者。這種治療可使超過4200萬名歐洲的哮喘患者受益,而哮喘在該地區的年社會成本預計爲460億歐元,且最多影響4%的普通人群。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生。


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