WASHINGTON (dpa-AFX) - AbbVie (ABBV) Thursday said it has submitted Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of glabellar lines.
The BLA submission is supported by data from two pivotal Phase 3 studies evaluating TrenibotE for the treatment of moderate to severe glabellar lines and a Phase 3 open-label safety study. All primary and secondary endpoints of the Phase 3 studies were met, with a rapid onset of action as early as 8 hours after drug administration and shorter duration of effect of 2-3 weeks.
If approved, TrenibotE will be the first neurotoxin of its kind available to patients, the company said in a statement.
Copyright(c) 2025 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2025 AFX News
