{"schema_version":"1.0","type":"article","title":"臨床試驗作假，FDA 撤市風暴！","url":"https://drugnews.com.tw/articles/2026-05-09-clinical-trial-fraud-fda-withdrawal.html","markdown_url":"https://drugnews.com.tw/articles/2026-05-09-clinical-trial-fraud-fda-withdrawal.md","lang":"zh-Hant","date":"2026-05-09","publish_at":"2026-05-09T10:30:00+08:00","updated_at":"2026-05-09","category":"商業分析系列","topic":"臨床與 CMC","tags":["Tavneos","FDA","資料完整性","罕病藥","撤市風險"],"summary":"FDA 對 Tavneos 提出撤市程序，核心不是單純療效不足，而是 ADVOCATE 試驗資料完整性與事後重判問題。","key_points":[],"facts":[],"sections":["Tavneos 面臨 FDA 撤市風暴：一款明星罕病藥，為什麼會從「類固醇替代希望」變成資料完整性教科書？","01｜Tavneos 曾經是一個非常漂亮的罕病藥故事","02｜真正引爆撤市程序的，不是普通瑕疵，而是 ADVOCATE 試驗的資料完整性問題","03｜安全性問題讓局勢更糟：DILI、VBDS 與死亡案例","04｜Tavneos 當初獲批，本來就不是一條毫無爭議的路","05｜EMA 也在重審：這已經不是美國單一監管事件","06｜這場風波真正傷到的，是 Biotech 資產併購的信任鏈","結語｜罕病藥不是免死金牌，資料完整性才是底線"],"references":[{"title":"[0]: 各公司官網＆公開資料","source":"","date":"","url":""},{"title":"[1]:","source":"","date":"","url":""},{"title":"CDER proposes to withdraw approval of TAVNEOS","source":"FDA","date":"","url":""},{"title":"CDER proposes to withdraw approval of TAVNEOS","source":"","date":"","url":""},{"title":"www.fda.gov","source":"","date":"","url":""},{"title":"\"CDER proposes to withdraw approval of TAVNEOS","source":"FDA\"","date":"","url":""},{"title":"[2]:","source":"","date":"","url":""},{"title":"AMGEN TO ACQUIRE CHEMOCENTRYX FOR $4 BILLION IN CASH| Amgen","source":"","date":"","url":""},{"title":"https://www.amgen.com/newsroom/press-releases/2022/08/amgen-to-acquire-chemocentryx-for-$4-billion-in-cash","source":"","date":"","url":"https://www.amgen.com/newsroom/press-releases/2022/08/amgen-to-acquire-chemocentryx-for-$4-billion-in-cash"},{"title":"www.amgen.com","source":"","date":"","url":""},{"title":"[3]:","source":"","date":"","url":""},{"title":"AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS","source":"","date":"","url":""},{"title":"/PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the fourth quarter and full year of 2025 versus the comparable periods in 2024....","source":"","date":"","url":""},{"title":"www.prnewswire.com","source":"","date":"","url":""},{"title":"[4]:","source":"","date":"","url":""},{"title":"EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA","source":"European Medicines Agency (EMA","date":"","url":""},{"title":"Review prompted by questions regarding data integrity of main study","source":"","date":"","url":""},{"title":"www.ema.europa.eu","source":"","date":"","url":""},{"title":"\"EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA","source":"European Medicines Agency (EMA)\"","date":"","url":""},{"title":"[5]:","source":"","date":"","url":""},{"title":"www.fda.gov","source":"","date":"","url":""},{"title":"https://www.fda.gov/media/192160/download","source":"","date":"","url":"https://www.fda.gov/media/192160/download"},{"title":"www.fda.gov","source":"","date":"","url":""},{"title":"\"Letter NOOH Taveneos (avacopan)\"","source":"","date":"","url":""},{"title":"[6]:","source":"","date":"","url":""},{"title":"FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis","source":"FDA","date":"","url":""},{"title":"FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis","source":"","date":"","url":""},{"title":"www.fda.gov","source":"","date":"","url":""},{"title":"\"FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis","source":"FDA\"","date":"","url":""},{"title":"[7]:","source":"","date":"","url":""},{"title":"reuters.com","source":"","date":"","url":""},{"title":"https://www.reuters.com/legal/litigation/fda-proposes-withdraw-amgens-rare-autoimmune-disease-drug-2026-04-28/","source":"","date":"","url":"https://www.reuters.com/legal/litigation/fda-proposes-withdraw-amgens-rare-autoimmune-disease-drug-2026-04-28/"},{"title":"www.reuters.com","source":"","date":"","url":""}],"images":[{"alt":"Dcard 原圖：臨床試驗作假，FDA 撤市風暴！","url":"https://drugnews.com.tw/assets/articles/clinical-trial-fraud-fda-withdrawal/dcard-01.webp"},{"alt":"Dcard 原圖：臨床試驗作假，FDA 撤市風暴！","url":"https://drugnews.com.tw/assets/articles/clinical-trial-fraud-fda-withdrawal/dcard-02.webp"},{"alt":"Dcard 原圖：臨床試驗作假，FDA 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