Boey (trenibotulinumtoxinE) Wins EU Approval as First Serotype E Neurotoxin for Frown Lines

The European Commission has approved trenibotulinumtoxinE (Boey), a first-in-class botulinum neurotoxin serotype E, for the temporary improvement of moderate to severe glabellar lines in adults for whom the lines carry significant psychological impact.¹ The decision, reached through the European Union's (EU) centralized procedure, applies across all 30 European Economic Area countries and follows Health Canada's approval of the product in June 2026.¹

"The EU approval of Boey marks an important step forward for our development program and builds on the momentum we've established with Health Canada's approval earlier this year," said Darin Messina, PhD, senior vice president of aesthetics research and development at AbbVie, in a company press release.¹ "This milestone reflects the scientific rigor behind Boey and reinforces our commitment to advancing innovative options as we work to bring this first-of-its-kind treatment to healthcare professionals and consumers around the world."¹

What clinical evidence supports the EU approval?

Approval is supported by two randomized, multicenter, double-blind, placebo-controlled phase 3 trials (M21-500 and M21-508) in adults with moderate to severe glabellar lines linked to corrugator and/or procerus muscle activity.¹ The trials enrolled 725 patients treated with Boey 700 U total dose or placebo, with the co-primary efficacy measure defined as the proportion of patients achieving a 2-grade or greater improvement from baseline in glabellar line severity at maximum frown, assessed separately by investigators and patients on the 4-point Facial Wrinkle Scale (FWS) at day 7.¹

AbbVie's June 2026 Health Canada approval announcement, describing the same two trials, reported day-7 composite responder rates of 60.0% (M21-500) and 65.7% (M21-508) versus placebo, based on efficacy-evaluable subgroups of 482 and 227 patients, respectively (p < .0001).³ The EU approval release does not restate these efficacy percentages.

Onset of effect was observed as early as 8 hours after treatment, with peak effect at day 7 and a return to baseline severity within approximately 2 to 3 weeks.¹ Reported adverse drug reactions in patients receiving Boey 700 U were eyelid ptosis (0.17%), brow ptosis (0.13%), and Mephisto sign, or lateral eyebrow elevation (0.04%).¹

How does Boey compare with the current standard of care?

Glabellar lines, the vertical furrows that form between the eyebrows at maximum frown, are a common cosmetic concern that can carry important psychological impact for some adults.¹ Botulinum neurotoxin serotype A products, including onabotulinumtoxinA (BOTOX Cosmetic), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA (Jeuveau), and daxibotulinumtoxinA (Daxxify), represent the current standard of care for this indication; these agents typically have a slower onset and longer duration of effect than the serotype E mechanism used in Boey.¹

TrenibotulinumtoxinE targets SNAP-25 and, owing to rapid neuronal uptake and translocation together with a short half-life of the type E light chain, produces faster onset and shorter duration of action than serotype A neurotoxins.¹ Serotype E's distinct ganglioside- and protein-co-receptor binding chemistry at the presynaptic membrane has been characterized structurally in prior peer-reviewed research, providing a mechanistic basis for this differentiated pharmacology.⁴ OnabotulinumtoxinA (BOTOX Cosmetic) is the only neurotoxin the company states has been clinically tested for safety in patients previously treated with Boey.¹

Allergan Aesthetics has positioned Boey for patients who are curious about facial injectables but hesitant to commit to longer-lasting results; company survey data cited in the release found 80% of respondents open to learning about new treatments and 79% wishing they could preview outcomes before committing.¹ This figure comes from company-sponsored market research rather than a peer-reviewed or epidemiological source.

What are the limitations and what comes next?

Boey remains investigational in the United States. FDA issued a complete response letter in April 2026 citing manufacturing-related questions on the biologics license application; the agency did not identify safety or efficacy concerns and did not request additional clinical studies.² AbbVie has said it intends to respond to FDA's manufacturing comments, but no updated US approval timeline has been disclosed.² Long-term safety and repeat-dosing data beyond the described trials were not detailed in the EU approval release.

References

1. Allergan Aesthetics (AbbVie). Allergan Aesthetics receives approval for Boey (trenibotulinumtoxinE), for use in Europe: the first and only rapid-onset, short-duration neurotoxin for the temporary improvement of frown lines in adult patients. Published July 17, 2026. Accessed July 17, 2026. https://news.abbvie.com/2026-07-17-Allergan-Aesthetics-receives-approval-for-Boey-R-trenibotulinumtoxinE-,-for-use-in-Europe-the-first-and-only-rapid-onset,-short-duration-neurotoxin-for-the-temporary-improvement-of-frown-lines-in-adult-patients
2. AbbVie. AbbVie Provides Update on TrenibotulinumtoxinE (TrenibotE) Biologics License Application in the U.S. Published April 23, 2026. Accessed July 17, 2026. https://news.abbvie.com/2026-04-23-AbbVie-Provides-Update-on-TrenibotulinumtoxinE-TrenibotE-Biologics-License-Application-in-the-U-S
3. Allergan Aesthetics (AbbVie). Allergan Aesthetics Receives Approval for Boey® (TrenibotulinumtoxinE) in Canada, the First and Only Rapid-Onset, Short-Duration Neurotoxin for the Temporary Improvement of Frown Lines in Adult Patients. Published June 23, 2026. Accessed July 17, 2026. https://www.prnewswire.com/news-releases/allergan-aesthetics-receives-approval-for-boey-trenibotulinumtoxine-in-canada-the-first-and-only-rapid-onset-short-duration-neurotoxin-for-the-temporary-improvement-of-frown-lines-in-adult-patients-302807467.html
4. Masuyer G, Davies JR, Stenmark P. Mechanism of Ganglioside Receptor Recognition by Botulinum Neurotoxin Serotype E. Int J Mol Sci. 2021;22(15):8315. doi:10.3390/ijms22158315