Allergan Aesthetics, part of AbbVie, has secured a major regulatory milestone for its Boey (trenibotulinumtoxinE) for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults.

 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Boey (trenibotulinumtoxinE) in adults where the condition has a significant psychological impact.

 

The decision marks a key step in the centralized EU review process. A final ruling from the European Commission is expected in the coming months and, if approved, would apply across all 30 European Economic Area countries.

 

“A positive opinion for Boey reflects years of scientific innovation and clinical development aimed at advancing botulinum toxin science,” said Roopal Thakkar, 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."

 

The CHMP backing is based on results from two pivotal Phase 3 trials, which evaluated efficacy and safety in adults with moderate to severe glabellar lines. 

 

According to the data, all primary and secondary endpoints were met, with onset of effect observed as early as eight hours after administration—the earliest timepoint assessed—and benefits lasting two to three weeks. Safety outcomes showed treatment-emergent adverse events were comparable to placebo, including across up to three consecutive treatments.

 

If granted approval, Allergan Aesthetics plans to begin training healthcare professionals on Boey use ahead of a commercial rollout in the coming months. Regulatory submissions are also underway in additional countries as the company seeks broader global approvals.