–TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration (earliest assessment time) and shorter duration of effect of 2-3 weeks.
–If approved, TrenibotE will be the first neurotoxin of its kind available to patients.
–Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program.
NORTH CHICAGO, IL, USA I April 24, 2025 I AbbVie (NYSE: ABBV) today announced submission of 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.
“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.”
New patients wanting to experience the aesthetic benefits of a neurotoxin cite “fear of looking unnatural” as a barrier to initiating neurotoxin use for aesthetic indications. If approved, TrenibotE will be the first serotype E neurotoxin offering patients the opportunity to experience a neurotoxin with rapid clinical effect for a shorter duration of time as a trial before getting treatment with BOTOX® Cosmetic.
The BLA submission is supported by data from over 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,” 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.”
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
– Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
– Moderate to severe lateral canthal lines associated with orbicularis oculi activity
– Moderate to severe forehead lines associated with frontalis activity
– Moderate to severe platysma bands associated with platysma muscle activity
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
SOURCE: AbbVie
Post Views: 2,355
–TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration (earliest assessment time) and shorter duration of effect of 2-3 weeks.
–If approved, TrenibotE will be the first neurotoxin of its kind available to patients.
–Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program.
NORTH CHICAGO, IL, USA I April 24, 2025 I AbbVie (NYSE: ABBV) today announced submission of 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.
“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.”
New patients wanting to experience the aesthetic benefits of a neurotoxin cite “fear of looking unnatural” as a barrier to initiating neurotoxin use for aesthetic indications. If approved, TrenibotE will be the first serotype E neurotoxin offering patients the opportunity to experience a neurotoxin with rapid clinical effect for a shorter duration of time as a trial before getting treatment with BOTOX® Cosmetic.
The BLA submission is supported by data from over 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,” 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.”
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
– Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
– Moderate to severe lateral canthal lines associated with orbicularis oculi activity
– Moderate to severe forehead lines associated with frontalis activity
– Moderate to severe platysma bands associated with platysma muscle activity
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
SOURCE: AbbVie
Post Views: 2,355