AbbVie declared that they had submitted the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE) to the United States FDA for the treatment of moderate to severe glabellar lines.
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.
Darin Messina
The “fear of looking unnatural” is cited by new patients who wish to benefit from the aesthetic effects of neurotoxins as a reason for not starting to use them for aesthetic purposes. TrenibotE, if approved, will be the first serotype E neurotoxin to give patients the chance to try a neurotoxin with a quick clinical effect for a shorter period of time as a trial before receiving BOTOX® Cosmetic therapy.
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), which included data from over 2,100 patients treated with TrenibotE in the clinical program, support the BLA submission. With a quick beginning of effect as early as 8 hours after drug administration (the earliest assessment period) and an observed efficacy duration of 2-3 weeks, all primary and secondary objectives of the Phase 3 studies were fulfilled. Both as a single treatment and for up to three consecutive sessions, TrenibotE’s treatment-emergent side effects were comparable to those of a placebo.
Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment,
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.
Cheryl Burgess
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