The EC has approved AbbVie's Boey (trenibotulinumtoxinE), the first serotype E neurotoxin for glabellar lines, with faster onset than current options.
The European Commission
What is Boey?
What is it approved for?
How fast does it work?
What data support approval?
Is it approved elsewhere?
"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
Approval is
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
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, a subsidiary of AbbVie, 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.
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.
