By VETTAPHARMA reporter – Derek Roche: Health Canada has approved AbbVie’s Boey® (trenibotulinumtoxinE) for the temporary improvement of moderate to severe glabellar (frown) lines in adults, making it the first and only rapid-onset, short-duration botulinum neurotoxin serotype E approved for aesthetic use.
Canada is also the first country globally to authorize a botulinum neurotoxin serotype E for cosmetic indications, marking a significant milestone in aesthetic medicine.
Boey is designed to provide a differentiated treatment option for adults seeking facial injectable treatments with a shorter duration of effect. Clinical studies showed that treatment effects may be observed as early as eight hours after injection, with results typically lasting approximately 14 to 21 days, substantially shorter than currently available botulinum toxin products. AbbVie noted that BOTOX Cosmetic® (onabotulinumtoxinA) is the only neurotoxin clinically evaluated following treatment with Boey.
The approval was supported by two pivotal Phase 3 randomized, multicenter, double-blind, placebo-controlled trials (M21-500 and M21-508) involving 947 adults with moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity. The primary endpoint assessed the proportion of participants achieving none or mild glabellar line severity with at least a two-grade improvement on the Facial Wrinkle Scale (FWS) at Day 7, based on both investigator and patient assessments. Composite responder rates reached 60.0% and 65.7% in the two studies (p<0.0001).
Secondary endpoints evaluated patient satisfaction using the Facial Line Satisfaction Questionnaire (FLSQ) and demonstrated improvements in treatment satisfaction and achievement of a natural appearance. The most frequently reported treatment-related adverse events were headache (3.4%), injection-site pain (1.7%), and injection-site erythema (0.6%). The product information also includes warnings regarding the potential distant spread of toxin effects, hypersensitivity reactions, localized muscle weakness, and swallowing or breathing difficulties associated with botulinum toxin therapy.
AbbVie plans to begin healthcare professional training in Canada ahead of a commercial launch in the coming months, while regulatory reviews of trenibotulinumtoxinE continue in multiple other countries.
Quick FAQs
1. What Is Boey?
Boey® (trenibotulinumtoxinE) is a botulinum neurotoxin serotype E developed by AbbVie’s Allergan Aesthetics for the temporary improvement of moderate to severe glabellar (frown) lines in adults.
2. What Happened?
Health Canada approved AbbVie’s Boey, making it the first approved botulinum neurotoxin serotype E for aesthetic use and the first rapid-onset, short-duration neurotoxin for treating glabellar lines.
3. What Studies Supported The Approval?
The approval was based on the Phase 3 M21-500 and M21-508 randomized, double-blind, placebo-controlled trials involving 947 adults with moderate to severe glabellar lines.
4. What Are Glabellar Lines?
Glabellar lines are the vertical wrinkles that develop between the eyebrows due to repeated contraction of the corrugator and procerus muscles during facial expressions such as frowning or squinting.
5. What Were The Key Results?
Boey demonstrated visible treatment effects as early as eight hours after injection, with 60.0% and 65.7% of patients achieving the primary efficacy endpoint by Day 7. Treatment effects typically returned to baseline within 14 to 21 days.
6. Why Is This Important?
The approval introduces the first botulinum neurotoxin serotype E for aesthetic use, offering patients and clinicians a rapid-onset, shorter-duration treatment option that may appeal to individuals seeking greater flexibility before committing to longer-lasting injectable therapies.
