2026-04-23 20:19:38 UTC / 路透社
作者：帕德马纳班·安南坦
2026年4月23日 世界协调时20:19 更新，距首次发布已过2小时
节点运行失败
2021年5月21日的资料照片中，艾伯维展示的logo前摆放着试管。路透社/达多·鲁维奇/插画 购买授权许可
艾伯维公司
美国食品药品监督管理局
4月23日（路透社）——艾伯维周四表示，美国食品药品监督管理局已拒绝批准其实验性除皱疗法曲尼保妥（trenibotE），理由是生产环节存在问题。
以下是详细信息：
通过路透社健康周刊（Reuters Health Rounds）时事通讯了解最新医学突破和医疗保健趋势。点击此处注册。
- 曲尼保妥是一款用于治疗皱眉纹等面部皱纹的肉毒杆菌毒素，其药效最早可在8小时后消退，而保妥适（Botox）的药效可持续两周以上。
- 花旗集团分析师杰夫·米查姆表示，此次挫折让艾伯维医美业务失去了一项短期增长催化剂，但市场对曲尼保妥的预期本就不高。
- 米查姆同时指出，与生产相关的审批要求很可能将获批时间推迟至2027年。
- 艾伯维补充称，监管机构未对该疗法的安全性或有效性提出质疑，也未要求开展新的患者研究。
- 该公司在医美市场占据主导地位，其保妥适疗法创造了数十亿美元的营收，该疗法可用于除皱、缓解偏头痛和治疗肌肉疾病。
- 该公司表示，曲尼保妥已在超过2100名患者中开展研究，包括两项晚期临床试验和一项安全性研究。
- 艾伯维表示，该疗法在其他国家的监管审查仍在进行中。
帕德马纳班·安南坦在班加罗尔报道；维贾伊·基肖尔编辑
我们的准则：汤森路透信托原则。
US FDA rejects AbbVie’s wrinkle treatment due to manufacturing concerns
2026-04-23 20:19:38 UTC / Reuters
By Padmanabhan Ananthan
April 23, 2026 8:19 PM UTC Updated 2 hours ago
节点运行失败
Test tubes are seen in front of a displayed Abbvie logo in this illustration taken, May 21, 2021. REUTERS/Dado Ruvic/Illustration Purchase Licensing Rights
Abbvie Inc
U.S. Food and Drug Administration
April 23 (Reuters) – AbbVie said on Thursday the U.S. Food and Drug Administration has declined to approve its experimental wrinkle treatment, trenibotE, citing issues in manufacturing.
Here are some details:
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- TrenibotE is a botulinum toxin for treating facial wrinkles such as frown lines, with effects wearing off as early as 8 hours compared to Botox’s duration of over two weeks.
- The setback removes a near-term catalyst for AbbVie’s aesthetics business, but Street expectations for trenibotE were modest, Citi analyst Geoff Meacham said.
- Meacham also noted that manufacturing‑related requests have likely delayed approval into 2027.
- AbbVie added the agency did not raise concerns about the treatment’s safety or efficacy, and did not ask for new patient studies.
- The company dominates the aesthetics market, generating multi-billion-dollar revenues from its Botox treatment, which are used for wrinkle smoothing, migraines and muscle disorders.
- The company said trenibotE has been studied in more than 2,100 patients, including two late-stage trials and a safety study.
- AbbVie said regulatory reviews of the treatment in other countries are still underway.
Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore
Our Standards: The Thomson Reuters Trust Principles.
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