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注射用E型肉毒毒素(TrenibotE)
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艾伯维(ABBV.US)1类新药国内报上市
Zhi Tong Cai Jing· 2025-10-14 00:48
Core Insights - AbbVie’s injection of E-type botulinum toxin (TrenibotE) has received acceptance for market application, classified as Category 1 [1] - The indication for TrenibotE is projected to be for moderate to severe glabellar lines based on clinical trial progress [1] Group 1 - TrenibotE is a first-in-class E-type botulinum neurotoxin, with the first market application submitted to the FDA in April 2025 [3] - The application is supported by clinical research data from over 2,100 patients treated with TrenibotE, including two pivotal Phase III studies (M21-500 and M21-508) and one Phase III open-label safety study (M21-509) [3] - All primary and secondary endpoints of the Phase III studies have been met, with effects observed as early as 8 hours post-administration and lasting for 2-3 weeks [3] Group 2 - Adverse events associated with TrenibotE treatment were similar to those of the placebo, regardless of whether it was a single treatment or up to three consecutive treatments [3]