Allergan Aesthetics, an AbbVie company (NYSE:ABBV) focused on medical aesthetics, announced on Thursday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Boey (trenibotulinumtoxinE) for the temporary improvement in the appearance of moderate to severe lines between the eyebrows seen at maximum frown (glabellar lines) in adult patients, when these have an important psychological impact.

The decision by the European Commission, expected in the coming months, would apply across the 30 European Economic Area (EEA) countries following completion of the centralised procedure.

The CHMP positive opinion is supported by data from two pivotal Phase 3 clinical trials evaluating the efficacy and safety of trenibotulinumtoxinE. All primary and secondary endpoints of the Phase 3 studies were met, with a rapid onset of action as early as eight hours after administration and observed efficacy duration for two to three weeks. Treatment-emergent adverse events for trenibotulinumtoxinE were similar to placebo, both as a single treatment and up to three consecutive treatments.

If approved, Allergan Aesthetics plans to start training healthcare professionals on the appropriate use of Boey ahead of a commercial launch in the upcoming months.

The product is also under review for marketing authorisation submissions in several other countries.