European Commission Approves Allergan Aesthetics' Boey for Temporary Improvement of Frown Lines

Boey approved across 30 European Economic Area countries

Allergan Aesthetics, an AbbVie company, announced that the European Commission has approved Boey (trenibotulinumtoxinE) for the temporary improvement in the appearance of moderate to severe glabellar lines in adults when the lines have an important psychological impact.

The approval applies across all 30 countries in the European Economic Area (EEA) following the completion of the centralized regulatory procedure.

Boey has also received regulatory approval in Canada earlier this year.

First botulinum neurotoxin serotype E approved in Europe

According to the company, Boey is the first and only rapid-onset and short-duration botulinum neurotoxin serotype E approved in Europe.

The treatment is designed to target glabellar lines, commonly known as frown lines, which appear vertically between the eyebrows.

Clinical studies showed that the onset of effect could be observed as early as eight hours after treatment. The effects lasted approximately two to three weeks, with the peak effect reported at Day 7.

The company said the shorter duration could offer an option for people who are interested in facial injectable treatments but are uncertain about committing to longer-lasting results.

Approval follows Phase 3 clinical studies

The European Commission's decision was supported by data from two randomized, multicenter, double-blind, placebo-controlled Phase 3 clinical studies, identified as M21-500 and M21-508.

The studies evaluated the safety and effectiveness of Boey in adults with moderate to severe glabellar lines associated with activity of the corrugator and/or procerus muscles.

A total of 725 patients participated in the studies and received either Boey at a total dose of 700 units or placebo.

The primary efficacy assessment looked at improvements in glabellar line severity at maximum frown. Researchers used the four-point Facial Wrinkle Scale, which ranges from no lines to severe lines, along with assessments from both investigators and patients.

The studies also included assessments of patient satisfaction with the treatment effect and whether patients felt the results looked natural.

Effects appeared within hours of treatment

Data from the two pivotal studies showed that the effects of Boey could begin as early as eight hours after injection.

The strongest effect was observed at Day 7. According to the clinical data, glabellar lines returned to their baseline severity in approximately two to three weeks following treatment.

This rapid onset and shorter duration are key features of Boey and differentiate it from longer-acting botulinum neurotoxin treatments.

Safety findings reported in clinical studies

The company reported that Boey was generally evaluated for safety and tolerability in the Phase 3 clinical programme.

Reported adverse drug reactions included eyelid ptosis, brow ptosis and Mephisto sign, which refers to lateral elevation of the eyebrow.

Among patients who received Boey at a 700-unit dose, these reactions were reported at rates of 0.17%, 0.13% and 0.04%, respectively.

Boey targets glabellar lines

Boey is a facial injectable botulinum neurotoxin serotype E that targets SNAP-25. According to the company, its mechanism allows rapid uptake and translocation into neuronal cells.

The short half-life of the type E light chain is intended to contribute to the product's rapid onset and shorter duration of effect when used for glabellar lines.

Glabellar lines are vertical lines that develop between the eyebrows and are often referred to as frown lines. In some adults, these lines may contribute to an appearance that is perceived as tired, angry or worried and can have an important psychological impact.

Allergan Aesthetics prepares for European launch

Allergan Aesthetics said it is preparing to launch Boey across Europe following the European Commission approval.

The company also plans to provide healthcare professionals with education and training on the appropriate use of the treatment.

Boey was developed by the makers of Botox Cosmetic, which is known as Vistabel or Vistabex in the European Union.

According to Allergan Aesthetics, Botox Cosmetic is the only neurotoxin that has been clinically tested for safety following treatment with Boey.

Company highlights growing interest in aesthetic treatments

The approval comes as interest in aesthetic treatments continues to grow, with patients increasingly looking for options that match their individual preferences and treatment goals.

Allergan Aesthetics cited survey data showing that 80% of people are open to learning about new treatments to achieve their desired results, while 79% said they would like the option to temporarily preview the outcome of an aesthetic treatment.

The company said some patients remain hesitant about aesthetic procedures because of uncertainty around results and concerns about committing to effects that last for a longer period.

Boey is being positioned as another option for suitable patients who are considering facial injectable treatments and may prefer a shorter-duration effect.

Company statement

Darin Messina, Ph.D., senior vice president of aesthetics research and development at AbbVie, said the European approval represents an important milestone for the Boey development programme.

He said the decision builds on the company's earlier regulatory approval in Canada and reflects the clinical development work supporting the treatment.

Allergan Aesthetics' portfolio

Allergan Aesthetics, an AbbVie company, develops, manufactures and markets products across the aesthetics sector.

Its portfolio includes facial injectables, body contouring products, plastic surgery products and skincare offerings.

The company said it is continuing to focus on research and development to bring new options to healthcare professionals and patients in the aesthetics market.

AbbVie is a global biopharmaceutical company focused on developing medicines and solutions for serious health conditions.

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