• Boey^® has received a positive opinion from the CHMP for 30 EU & EEA markets
• If approved, Boey^® has the potential to be the first and only botulinum neurotoxin serotype E that adult patients can try for the temporary improvement of Glabellar Lines
• Positive opinion is supported by data from two pivotal Phase 3 trials, which demonstrated rapid results as early as 8 hours and duration of 2-3 weeks²

Allergan Aesthetics, an AbbVie company (NYSE: ABBV) and global leader in medical aesthetics, announced 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 European Commission decision, expected in the coming months, would apply across the 30 European Economic Area (EEA) countries following completion of the centralized procedure.

"A positive opinion for Boey^® reflects years of scientific innovation and clinical development aimed at advancing botulinum toxin science," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We strongly believe Boey has the potential to offer a differentiated treatment option for many people who are still considering facial injectables^*1."

The CHMP positive opinion is supported by data from two pivotal Phase 3 clinical trials evaluating the efficacy and safety of trenibotulinumtoxinE in adult subjects with moderate to severe glabellar lines (M21-500 and M21-508). 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 (the earliest assessment time) 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.²

If approved, Allergan Aesthetics plans to begin training healthcare professionals on the appropriate use of Boey^® and is preparing for a commercial launch in the upcoming months. Marketing authorization submissions for trenibotulinumtoxinE are also under review in multiple other countries.