- AbbVie (ABBV, Financial) submits Biologics License Application to the FDA for TrenibotulinumtoxinE (TrenibotE).
- TrenibotE is a first-in-class serotype E neurotoxin with a rapid 8-hour onset and a short 2-3 week duration.
- Over 2,100 patients were involved in successful Phase 3 clinical trials supporting the BLA submission.
AbbVie Inc. (ABBV) has taken a significant step forward in the field of facial aesthetics by submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for TrenibotulinumtoxinE (TrenibotE). This first-in-class botulinum neurotoxin is designed to treat moderate to severe glabellar lines, offering a rapid onset of action within 8 hours and a duration lasting 2-3 weeks, a notable difference from traditional neurotoxin treatments.
The BLA submission for TrenibotE is substantiated by comprehensive clinical data from over 2,100 patients, covering multiple Phase 3 studies. These studies successfully met all primary and secondary endpoints, showing treatment-emergent adverse events similar to placebo. If approved, TrenibotE will be the inaugural serotype E neurotoxin available, providing a new, shorter-duration option for those hesitant about longer-lasting treatments like BOTOX® Cosmetic.
This development aims to address common concerns about neurotoxin treatments, such as the “fear of looking unnatural,” by offering an introductory trial treatment suitable for new patients interested in facial aesthetics. The FDA's decision on the approval of TrenibotE will dictate its availability, as the application was submitted in April 2025.
