Allergan Aesthetics, an AbbVie company, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The recommendation supports approval of Boey (trenibotulinumtoxinE) in the European Union.
Key regulatory milestone for Boey
The decision marks a key regulatory milestone for the injectable treatment. It targets temporary improvement of moderate to severe glabellar lines in adults. These lines appear between the eyebrows during maximum frown.
The CHMP opinion covers all 30 countries within the European Economic Area. The recommendation follows completion of the centralised EU regulatory procedure. The European Commission will now review the opinion before issuing a final decision.
Next step toward EU approval
If approved, Boey could become available across multiple European markets simultaneously. The treatment is designed for adults whose frown lines create psychological concern. Regulators evaluate both safety and efficacy before granting marketing authorisation.
Phase 3 clinical trial results
The positive opinion is based on data from two Phase 3 clinical trials. The studies evaluated efficacy and safety in adults with moderate to severe glabellar lines. Both trials met their primary and secondary endpoints.
Clinical results showed a rapid onset of action within eight hours of treatment. Researchers recorded the earliest effects at the first evaluation point. The treatment also demonstrated a duration of action lasting two to three weeks.
Safety profile findings
Safety findings showed treatment-emergent adverse events similar to placebo. Patients received single or multiple treatment cycles during the studies. Researchers reported no unexpected safety signals during the trial period.
Allergan Aesthetics stated it will prepare for potential launch activities. The company plans to train healthcare professionals on proper use of Boey. It also continues regulatory submissions in additional global markets.
European Commission decision ahead
The European Commission decision is expected in the coming months. Final approval would allow commercial rollout across the EU and EEA region. The outcome will determine Boey’s entry into the European aesthetics market.
Also read: Allergan Aesthetics launches Skin Quality Index for patients