AbbVie Submits Biologics License Application to FDA for Novel Serotype E Botulinum Neurotoxin in Moderate to Severe Glabellar Lines

AbbVie has submitted a Biologics License Application (BLA) to the FDA for TrenibotE (trenibotulinumtoxinE), a novel serotype E botulinum neurotoxin, for the treatment of moderate to severe glabellar lines. The submission is based on data from two pivotal Phase III trials (M21-500 and M21-508) as well as a long-term safety study, all of which met their primary and secondary endpoints.¹

"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, SVP, aesthetics R&D, AbbVie, in a press release. "TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category."

The two pivotal studies included 947 adult patients with moderate to severe glabellar lines located between the eyebrows. All patients were either previously treated with neurotoxins or were toxin-naïve, with evaluations over 12 weeks and up to two treatments of TrenibotE. The primary endpoint of both studies was improvement in glabellar line severity on the Facial Wrinkle Scale (FWS) from baseline at day seven compared to placebo. A key secondary endpoint was patient-reported outcomes on overall treatment satisfaction.

Results from both studies demonstrated clinical significance, with TrenibotE demonstrating a rapid onset of action as early as eight hours post-treatment and an efficacy duration of two to three weeks. The safety profile of TrenibotE was found to be comparable to placebo, with similar rates of treatment-emergent adverse events in both groups, after both a single treatment and up to two consecutive treatments.^1,2

"Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment," said Cheryl Burgess, MD, FAAD, lead clinical investigator for one of the Phase II studies, in the press release. "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."

References

1. AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines. AbbVie. April 24, 2025. Accessed April 24, 2025. https://news.abbvie.com/2025-04-24-AbbVie-Submits-Biologics-License-Application-to-U-S-FDA-for-TrenibotulinumtoxinE-TrenibotE-for-the-Treatment-of-Glabellar-Lines

2. Allergan Aesthetics Announces Positive Topline Results from Two Pivotal Phase 3 Studies of TrenibotulinumtoxinE (BoNT/E) for the Treatment of Glabellar Lines. AbbVie. October 24, 2023. Accessed April 24, 2025. https://news.abbvie.com/2023-10-24-Allergan-Aesthetics-Announces-Positive-Topline-Results-from-Two-Pivotal-Phase-3-Studies-of-TrenibotulinumtoxinE-BoNT-E-for-the-Treatment-of-Glabellar-Lines