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北京时间·🕒 发布 07-24 21:45:59时区推断·⟳ 抓取 07-24 21:47:42·⚡ 决策 07-25 12:26:44 +14h39m·94.1 天前
安进向FDA提交Tavneos新证据以挑战撤市提议
当前新增事实是安进提交70多项真实世界研究、2200多名患者数据以争取听证，方向是对既有撤市风险的防御性缓释。
📄 原文Reuters↗ 原文
Amgen (AMGN.O) said on Friday it submitted new evidence to the FDA on July 23 as it seeks a hearing to challenge the p…
不做 安进（AMGN.US）
防御性监管进展尚未改变FDA撤市风险，且Tavneos相对安进体量太小，不做。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
🔎 新鲜度:最早出现 2026-07-24 · 扩散 medium · price-in 风险 medium ↗
消息传播链
- 2026-04官方确认/否认FDA声称一手 · 未核验FDA此前已提议撤回Tavneos美国上市许可，称有效性证据不足且原申请存在虚假陈述。
- 2026-06官方确认/否认欧洲药品监管机构声称一手 · 未核验欧洲监管方建议撤销Tavneos批准，理由包括研究数据可靠性问题。
- 路透报道安进7月23日向FDA提交新证据并寻求听证。
关键理由
- 当前新增事实是安进提交70多项真实世界研究、2200多名患者数据以争取听证，方向是对既有撤市风险的防御性缓释。
- FDA撤市提议、76例严重肝损伤含8例死亡、欧洲药监撤销建议均为此前已披露负面背景，不是本条新增净利空。
- Tavneos为罕见病药物，相对安进收入和市值体量过小，难以形成AMGN短线市值级交易催化。
主要风险
- FDA若最终下令撤市会继续压制Tavneos价值，但当前事件尚未改变监管结论。
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原文全文
展开原文 · 1,630 字
Amgen (AMGN.O) said on Friday it submitted new evidence to the FDA on July 23 as it seeks a hearing to challenge the proposed withdrawal of its rare-disease drug Tavneos from the U.S. market.
The U.S. Food and Drug Administration in April proposed withdrawing the drug, which treats a rare autoimmune disease that damages blood vessels, citing a lack of proven effectiveness and false statements in its original marketing application.
Here are some details:
Amgen said it strongly disagrees with the FDA and that its submission includes more than 70 real-world studies involving over 2,200 patients supporting the drug’s effectiveness and safety.
The drug developer said the Duke Clinical Research Institute, which it had commissioned to independently review the pivotal trial, found Tavneos matched a steroid treatment regimen at 26 and 52 weeks, although it did not reproduce the original finding of superiority at 52 weeks.
The FDA did not immediately respond to a Reuters request for comment.
The health regulator in March had separately identified 76 cases of serious liver injury linked to Tavneos, including eight deaths and seven cases of a rare condition that can cause permanent liver damage.
In June, Europe's drug regulator recommended revoking the drug's approval, citing unreliable study data.
Tavneos treats severe active ANCA-associated vasculitis, a rare disease that inflames blood vessels and can damage organs including the kidneys and lungs.
The FDA said in April that Tavneos would remain on the U.S. market unless Amgen removes it or the FDA commissioner orders its withdrawal.
The U.S. Food and Drug Administration in April proposed withdrawing the drug, which treats a rare autoimmune disease that damages blood vessels, citing a lack of proven effectiveness and false statements in its original marketing application.
Here are some details:
Amgen said it strongly disagrees with the FDA and that its submission includes more than 70 real-world studies involving over 2,200 patients supporting the drug’s effectiveness and safety.
The drug developer said the Duke Clinical Research Institute, which it had commissioned to independently review the pivotal trial, found Tavneos matched a steroid treatment regimen at 26 and 52 weeks, although it did not reproduce the original finding of superiority at 52 weeks.
The FDA did not immediately respond to a Reuters request for comment.
The health regulator in March had separately identified 76 cases of serious liver injury linked to Tavneos, including eight deaths and seven cases of a rare condition that can cause permanent liver damage.
In June, Europe's drug regulator recommended revoking the drug's approval, citing unreliable study data.
Tavneos treats severe active ANCA-associated vasculitis, a rare disease that inflames blood vessels and can damage organs including the kidneys and lungs.
The FDA said in April that Tavneos would remain on the U.S. market unless Amgen removes it or the FDA commissioner orders its withdrawal.
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