Allergan Aesthetics Receives Positive CHMP Opinion for Boey® (TrenibotulinumtoxinE) for the Temporary Improvement of Moderate to Severe Glabellar Lines in Adults
- Boey® has received a positive opinion from the CHMP for 30 EU & EEA markets
- If approved, Boey® has the potential to be the first and only botulinum neurotoxin serotype E that adult patients can try for the temporary improvement of Glabellar Lines
- Positive opinion is supported by data from two pivotal Phase 3 trials, which demonstrated rapid results as early as 8 hours and duration of 2-3 weeks2
"A positive opinion for Boey® reflects years of scientific innovation and clinical development aimed at advancing botulinum toxin science," said
The CHMP positive opinion is supported by data from two pivotal Phase 3 clinical trials evaluating the efficacy and safety of trenibotulinumtoxinE in adult subjects with moderate to severe glabellar lines (M21-500 and M21-508). All primary and secondary endpoints of the Phase 3 studies were met, with a rapid onset of action as early as eight hours after administration (the earliest assessment time) and observed efficacy duration for two to three weeks. Treatment-emergent adverse events for trenibotulinumtoxinE were similar to placebo, both as a single treatment and up to three consecutive treatments.2
If approved, Allergan Aesthetics plans to begin training healthcare professionals on the appropriate use of Boey® and is preparing for a commercial launch in the upcoming months. Marketing authorization submissions for trenibotulinumtoxinE are also under review in multiple other countries.
About Glabellar Lines
Glabellar lines are vertical lines that appear between the eyebrows, commonly known as frown lines. In some adults, these lines can contribute to an appearance that is perceived as tired, angry or worried and may have an important psychological impact.
About Allergan Aesthetics
Allergan Aesthetics, an AbbVie company, develops, manufactures and markets 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, neuroscience and oncology – 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.
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FOOTNOTES * Survey conducted for Allergan Aesthetics. Online interviews conducted in REFERENCES
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SOURCE AbbVie
