Posted by Michael Wonder on 23 Apr 2026
AbbVie provides update on trenibotulinumtoxinE (TrenibotE) biologics license application in the US
23 April 2026 - AbbVie today announced that it received a complete response letter from the US FDA regarding the biologics license application for trenibotulinumtoxinE (TrenibotE), a first-in-class botulinum neurotoxin serotype E with a rapid onset of effect and short duration.
In its letter, the FDA requested additional information about manufacturing processes. The complete response letter does not identify any safety or efficacy concerns for TrenibotE, and does not request additional clinical studies. AbbVie is confident that it can address the FDA's comments promptly and expects to submit a thorough response in the coming months.
