AbbVie Files FDA Application For TrenibotE, A Fast-Acting Neurotoxin For Aesthetic Use

AbbVie has submitted a Biologics License Application (BLA) to the U.S. FDA for trenibotulinumtoxinE (TrenibotE), a new aesthetic neurotoxin candidate designed to treat moderate to severe glabellar lines. If approved, TrenibotE would become the first serotype E neurotoxin available in the U.S., offering patients a quicker onset and shorter duration treatment option.

Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie, said, "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. TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category."

The motivation behind developing TrenibotE stems from concerns among new patients who are hesitant to try neurotoxin treatments due to fears of unnatural results. TrenibotE’s unique profile with results noticeable within 8 hours and lasting for 2–3 weeks provides a lower-commitment option that could ease those concerns and serve as a stepping stone to longer-acting neurotoxins like BOTOX® Cosmetic.

"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 3 studies. "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."

The BLA submission is backed by data from over 2,100 patients across multiple Phase 3 clinical trials. These studies demonstrated that TrenibotE met all primary and secondary endpoints, with safety outcomes comparable to placebo even after repeated treatments.