Allergan Aesthetics Submits BLA for TrenibotulinumtoxinE for Glabellar Lines

Allergan Aesthetics, an AbbVie Company, has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE), seeking approval for the treatment of moderate to severe glabellar lines.

TrenibotE, a serotype E botulinum toxin, is positioned as a novel option for patients new to aesthetic neurotoxins, offering a rapid onset of effect and shorter treatment duration. Clinical studies demonstrated a response as early as eight hours post-administration and an efficacy window of two to three weeks.

"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, Ph.D., 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."

The BLA submission is supported by data from over 2,100 patients across two pivotal Phase 3 trials (M21-500 and M21-508) and an open-label safety study (M21-509). All primary and secondary endpoints were met. Safety profiles showed treatment-emergent adverse events comparable to placebo, even after up to three consecutive treatments.

In a press release, AbbVie highlights that fear of unnatural appearance remains a significant barrier for patients considering neurotoxin treatments. TrenibotE may help address these concerns by offering a shorter-term aesthetic result, providing an introductory experience before patients commit to longer-acting treatments such as onabotulinumtoxinA (BOTOX® Cosmetic).

Cheryl Burgess, MD, FAAD, was lead investigator for one of the pivotal Phase 3 studies. She emphasized in a press release how the product could empower patients’ aesthetic journeys. 

"Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment," said Dr. Burgess. "Treatment with a product offering rapid onset of effect and short duration of action could help address this barrier and empower confidence for patients exploring their aesthetics treatment journey with innovation from the makers of BOTOX® Cosmetic."