Allergan Aesthetics, a unit of AbbVie (NYSE: ABBV), announced that Health Canada has approved Boey® (trenibotulinumtoxinE) for the temporary improvement of moderate to severe glabellar lines in adult patients.

According to the company, Boey is the first botulinum neurotoxin based on serotype E to receive regulatory approval for aesthetic use anywhere in the world. The product's effects can appear as early as eight hours after injection, with results typically lasting approximately two to three weeks before returning to baseline.

The approval is supported by data from two Phase 3, randomized, double-blind, placebo-controlled trials enrolling 947 patients treated with Boey or placebo. The composite responder rates at Day 7 were 60.0% and 65.7% across the two studies. The most frequently reported treatment-related adverse events were headache, injection site pain, and injection site erythema, all of which occurred at similar or lower rates in the Boey-treated group compared with placebo.

Allergan Aesthetics noted that Botox Cosmetic® (onabotulinumtoxinA) is the only neurotoxin clinically tested for use following treatment with Boey. The company said it plans to begin training healthcare professionals and is preparing for a commercial launch in Canada in the coming months. The company also said trenibotulinumtoxinE is under regulatory review in multiple other countries.

The press release noted that one unit of Boey is not equivalent to one unit of other botulinum toxin products, and that the product carries warnings about the potential distant spread of toxin effects, which can include difficulty breathing and swallowing.