AbbVie (NYSE: ABBV), a Chicago-based pharmaceutical company, announced on Thursday that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines, vertical lines that appear between the eyebrows and nose, particularly when frowning.

The company says that the BLA submission is supported by data from over 2,100 patients treated with TrenibotE in the clinical program, which included two pivotal Phase 3 clinical studies evaluating TrenibotE for the treatment of moderate to severe glabellar lines (M21-500 and M21-508) and a Phase 3 open-label safety study (M21-509). 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 (the earliest assessment time) and observed efficacy duration for 2-3 weeks. Topline data from the Phase 3 pivotal studies were previously shared.

"The submission provides evidence of TrenibotE's differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an introduction to a neurotoxin," said Darin Messina, PhD, senior vice president, aesthetics R&D, AbbVie. "TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category."