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              2018年7月FDA批準上市新藥TECOVIRIMAT
              2018-07-15 17:34:32 來源:有機化學網 瀏覽:4868

              2018年7月14日,美國FDA宣布批準SIGA Technologies的新藥TPOXX(tecovirimat)上市,治療天花(smallpox)。值得一提的是,這是美國FDA今年批準的第21款新藥,也是首款獲批治療天花的新藥。

              天花這個名字,想必生物醫藥行業的讀者都不會陌生。天花疫苗是人類成功開發的第一款疫苗,讓我們對這種致命的疾病有了預防的武器。自天花疫苗的接種普及以來,人類在與病毒的戰爭中取得了節節勝利。1980年,世界衛生組織宣布,我們已經消除了天花的威脅。這種一度影響廣泛,令人談之色變的傳染性疾病,也逐漸淡出了人們的視野。

              但隨著這幾十年來的國際形勢復雜化,人們開始擔心天花病毒可能被制成生物武器,威脅到普通百姓的生命。因此,人們也決定開發出一款能治療天花的藥物,以備不時之需。TPOXX就這樣應運而生。作為一款抗病毒藥物,它能有效針對天花病毒在體內的傳播。基于它的潛力,這款新藥曾獲得了快速通道資格、優先審評資格、以及孤兒藥資格。

              這款新藥的療效與安全性在動物實驗和人體試驗中分別得到了檢驗。在動物實驗中,感染了類天花病毒后,使用TPOXX的動物比使用安慰劑的對照組動物,要活得更久。而在人體試驗中,研究人員們招募了359名健康志愿者(沒有天花感染),并讓他們使用了TPOXX。研究表明最常見的副作用是頭痛、惡心、以及腹部疼痛,沒有嚴重的副作用。基于動物實驗中展現出的療效,以及人體試驗表明的安全性,美國FDA批準了這款新藥上市。

              “為了應對生物恐怖襲擊的危險,國會已采取措施,確保病原體被當做武器時,我們有經過開發并獲批的反制手段。今日的批準代表了這些努力的重大里程碑!”美國FDA局長Scott Gottlieb博士說道:“這是首個被授予‘Material Threat Medical Countermeasure’優先審評券的新藥。今天的批準也表明美國FDA的承諾,即確保我們已經為公共健康危機做好了準備,能及時提供安全有效的新藥產品。”

              盡管這款新藥有望能對天花進行治療,我們仍然期待天花不會卷土重來,也期待人類永遠沒有用上這款新藥的那一天。

              tecovirimat結構式:

               

              CAS No.: 816458-31-8
              Synonyms:
                Formula: C19H15F3N2O3
                Exact Mass: 376.10300
                Molecular Weight: 376.32900

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