AbbVie 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.

TrenibotE is a potential first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as eight hours after administration (earliest assessment time) and shorter duration of effect of two to three weeks.

Two Phase 3 Studies

The BLA submission is supported by data from more than 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. Treatment-emergent adverse events for TrenibotE were similar to placebo, both as a single treatment and up to three consecutive treatments.

Topline data from the Phase 3 pivotal studies were previously shared.

“Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment,” says Cheryl Burgess, MD, a Dermatologist in Washington, DC, and 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.”