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北京时间·🕒 发布 16:26:24·⟳ 抓取 16:30:35 +4m11s·⚡ 决策 08-27 17:25:11 +54m36s·61.1 天前
AbbVie向EMA提交SKYRIZI皮下注射诱导治疗克罗恩病的监管申请
search_processed_events命中同一具体催化（08-27 08:45 UTC，news_center，ticker ABBV.US，标题完全一致），本条信号无新增金额、指引修正、官方确认/否认或监管进展等足以改变结论的事实，属于重复消息。
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AbbVie Seeks EMA Nod For SKYRIZI Subcutaneous Induction In Crohn's Disease
AbbVie (ABBV) announced that it has submitted a regulatory application to the European Medicines Agency for SKYRIZI sub…
不做 AbbVie（ABBV.US）
重复消息：同一具体催化（AbbVie向EMA提交SKYRIZI SC诱导申请）已于08:45 UTC被处理并判定不做。本条无新增金额、指引修正或监管进展。事件本身为已公开AFFIRM数据后的程序性申报，对超大市值AbbVie（市值约$4700亿）短线预期差不足，盘前股价反跌1.07%亦无正向反应。
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研究档案
结论摘要
AbbVie向EMA提交SKYRIZI SC诱导补充申请，基于2026年3月已公布的AFFIRM阳性数据，是既有获批产品的给药路径扩展而非新适应症。该事件已于08:45 UTC被同源处理并判定不做（超大市值+无量化增量+未获批）。本条无新增事实，确认为重复消息，维持不做。
🔎 新鲜度:最早出现 2026-08-27 · 扩散 medium · price-in 风险 high ↗
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原文全文
展开原文 · 2,304 字
AbbVie (ABBV) announced that it has submitted a regulatory application to the European Medicines Agency for SKYRIZI subcutaneous induction in adult patients with moderately to severely active Crohn's disease.
Crohn's disease (CD) is a chronic inflammatory condition of the gastrointestinal tract that can cause persistent diarrhea, abdominal pain, and serious complications over time. Current treatment options often require intravenous (IV) induction, which can be burdensome for patients. AbbVie's submission aims to expand access by offering a subcutaneous (SC) induction route, complementing the already approved intravenous (IV) induction regimen.
The application is supported by the positive results from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of Risankizumab SC induction in adults with Crohn's disease, including those who had previously failed advanced therapies. The study met its co-primary endpoints, showing clinical remission and endoscopic response at week 12, with a safety profile consistent with prior SKYRIZI data.
AbbVie highlighted that SKYRIZI (risankizumab), an IL-23 inhibitor, has already been approved in the European Union since 2022 as the first specific IL-23 therapy for Crohn's disease. If the new application is approved, patients will have the flexibility to begin treatment with either SC injection or IV infusion, followed by SC maintenance dosing every eight weeks.
This submission underscores AbbVie's commitment to advancing treatment approaches in gastroenterology and expanding patient choice in induction therapy. SKYRIZI is also approved for plaque psoriasis, psoriatic arthritis, and ulcerative colitis, reflecting its broad role in immune-mediated conditions.
ABBV has traded between $109.75 and $267.47 over the past year. The stock closed Wednesday's trading at $262.90, up 1.09%. In pre-market trading the stock is at $260.01, down 1.07%.
For comments and feedback contact: editorial@rttnews.com
Business News
August 21, 2026 14:42 ET The minutes of the latest policy meeting of the Federal Reserve, housing market data and manufacturing sector survey results were the main news for the U.S. economy this week. In Europe, inflation data from the U.K. was the highlight, while consumer price data from Japan drew attention in Asia.
Crohn's disease (CD) is a chronic inflammatory condition of the gastrointestinal tract that can cause persistent diarrhea, abdominal pain, and serious complications over time. Current treatment options often require intravenous (IV) induction, which can be burdensome for patients. AbbVie's submission aims to expand access by offering a subcutaneous (SC) induction route, complementing the already approved intravenous (IV) induction regimen.
The application is supported by the positive results from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of Risankizumab SC induction in adults with Crohn's disease, including those who had previously failed advanced therapies. The study met its co-primary endpoints, showing clinical remission and endoscopic response at week 12, with a safety profile consistent with prior SKYRIZI data.
AbbVie highlighted that SKYRIZI (risankizumab), an IL-23 inhibitor, has already been approved in the European Union since 2022 as the first specific IL-23 therapy for Crohn's disease. If the new application is approved, patients will have the flexibility to begin treatment with either SC injection or IV infusion, followed by SC maintenance dosing every eight weeks.
This submission underscores AbbVie's commitment to advancing treatment approaches in gastroenterology and expanding patient choice in induction therapy. SKYRIZI is also approved for plaque psoriasis, psoriatic arthritis, and ulcerative colitis, reflecting its broad role in immune-mediated conditions.
ABBV has traded between $109.75 and $267.47 over the past year. The stock closed Wednesday's trading at $262.90, up 1.09%. In pre-market trading the stock is at $260.01, down 1.07%.
For comments and feedback contact: editorial@rttnews.com
Business News
August 21, 2026 14:42 ET The minutes of the latest policy meeting of the Federal Reserve, housing market data and manufacturing sector survey results were the main news for the U.S. economy this week. In Europe, inflation data from the U.K. was the highlight, while consumer price data from Japan drew attention in Asia.
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