Allergan Aesthetics receives approval for Boey® (trenibotulinumtoxinE), for use in Europe: the first and only rapid-onset, short-duration neurotoxin for the temporary improvement of frown lines in adult patients
Rhea-AI Summary
Allergan Aesthetics (NYSE: ABBV) announced that the European Commission has approved Boey® (trenibotulinumtoxinE) for the temporary improvement of moderate to severe glabellar lines (frown lines) at maximum frown in adult patients, when these lines have an important psychological impact. The centralized decision applies across all 30 European Economic Area countries.
Boey® is described as the first and only rapid-onset, short-duration botulinum neurotoxin serotype E approved in Europe; in clinical studies, onset of effect was observed as early as eight hours and typically lasted two to three weeks. Boey® also received approval in Canada in June 2026. According to Allergan Aesthetics, the product was developed to offer a differentiated, shorter-acting option for adults considering facial injectables, allowing them to experience treatment results without committing to longer-lasting effects. The company plans a European launch supported by education and training for healthcare professionals. BOTOX® Cosmetic is noted as the only neurotoxin clinically tested for safety following treatment with Boey®.
Positive
- EU approval for Boey® covering 30 EEA countries
- First approved rapid-onset, short-duration serotype E neurotoxin in Europe
- Clinical onset of effect as early as eight hours
- Effect duration typically two to three weeks in studies
- Boey® also received Canadian approval in June 2026
Negative
- None.
News Market Reaction – ABBV
In the Jul 17 session, ABBV gained 0.04%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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Key Terms
glabellar lines medical
botulinum neurotoxin medical
platysma bands medical
myasthenia gravis medical
european economic area (eea) regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Boey® is the first and only rapid-onset and short-duration botulinum neurotoxin serotype E approved in
Europe that adult patients can try for the temporary improvement of glabellar lines¹ - Results may be seen as early as eight hours after treatment and typically wear off within approximately two to three weeks
- Boey® offers a differentiated treatment option for many people who are curious about facial injectables²
Following completion of the centralized procedure, the European Commission decision applies across all 30 European Economic Area (EEA) countries. Boey® also received approval in
Boey® is the first and only rapid-onset and short-duration botulinum neurotoxin serotype E approved in
"The EU approval of Boey® marks an important step forward for our development program and builds on the momentum we've established with Health Canada's approval earlier this year," said Darin Messina, Ph.D., senior vice president, aesthetics research & development, AbbVie. "This milestone reflects the scientific rigor behind Boey® and reinforces our commitment to advancing innovative options as we work to bring this first-of-its-kind treatment to healthcare professionals and consumers around the world."
As interest in aesthetic treatments continues to grow, patients are increasingly seeking treatment options that align with their individual goals and preferences. An Allergan Aesthetics survey found that
Developed by the makers of BOTOX Cosmetic®, known as VISTABEL® or Vistabex® in the EU, Boey® offers a new option for suitable patients considering facial injectables. BOTOX Cosmetic® is the only neurotoxin clinically tested for safety following treatment with Boey®.1
Allergan Aesthetics is preparing to launch Boey® across
Allergan Aesthetics develops, manufactures and markets a portfolio of leading aesthetics brands and products. Allergan Aesthetics is well positioned to lead the future of injectable aesthetics, with dedicated research and development focused on driving innovation to meet the evolving needs of patients and healthcare professionals worldwide.
BOTOX® COSMETIC US APPROVED USES AND IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, frown lines between the eyebrows, and vertical bands connecting the jaw and neck (platysma bands) in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
Problems swallowing, speaking, or breathing, due to weakening of associated muscles, which can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months.
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, forehead lines, and/or platysma bands.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or fain.
Do not receive BOTOX® Cosmetic if you are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg); or have a skin infection at the planned injection site. This list may not include all available botulinum toxin products.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing, from standard doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including surgery or plans to have surgery on your face, trouble raising your eyebrows, drooping eyelids, any other abnormal facial change, are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby), or are breastfeeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, or Letybo in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; or take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems, including double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of eyelids, and dry eyes.
For more information, refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan Aesthetics at 1-800-678-1605.
Please see BOTOX® Cosmetic full US Product Information, including Boxed Warning and Medication Guide.
About Boey®
Boey® is a facial injectable neurotoxin serotype E that targets SNAP-25. It has a rapid uptake and translocation into neuronal cells, with a short half-life of the type E light chain, giving it a rapid onset of action and a short duration of effect when treating glabellar lines.
About Boey® Clinical Trials
The approval of Boey® is supported by data from two randomised, multi-centre, double-blind, placebo-controlled studies Phase 3 clinical trials evaluating the efficacy and safety of Boey® in adults with moderate to severe glabellar lines (M21-500 and M21-508) associated with corrugator and/or procerus muscle activity, who were psychologically impacted by their glabellar lines. The studies enrolled 725 patients treated with Boey® 700 U total dose or placebo. The co-primary efficacy measure (treatment effect) was defined as the percentage of subjects achieving a ≥2-grade improvement from baseline in glabellar line severity at maximum frown based separately on investigator and subject assessments using the 4-point Facial Wrinkle Scale (FWS) (0=none, 1=mild, 2=moderate, 3=severe) at Day 7. Efficacy was assessed in the ITT population with baseline FLO-11 Total Transformed Score of ≤50. Secondary efficacy endpoints were measured by FLSQ, a scale developed by Allergan Aesthetics, and included satisfaction with achieving a natural look (Item 4) and overall satisfaction with treatment effect (Item 5).
The onset of effect for patients treated with Boey® appeared as early as 8 hours after injection in both pivotal studies. The peak effect was seen at Day 7 in both studies. Glabellar lines returned to baseline severity in approximately 2 to 3 weeks after administration.
The adverse drug reactions associated with Boey® were eyelid ptosis, brow ptosis, and Mephisto sign (lateral elevation of eyebrow). These reactions were reported in
About Glabellar Lines
Glabellar lines are the vertical lines that appear between the eyebrows, commonly known as frown lines. In some adults, these lines can contribute to an appearance that is perceived as tired, angry or worried and may have an important psychological impact.
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Global Media: Michael Salzillo | Investors: Liz Shea |
Footnotes
*Customer survey research carried out across nine countries that included online data collection and a 20-minute self-administered closed questionnaire conducted between November to December 2025. 12,286 participants (
References
- Boey® Summary of Product Characteristics. AbbVie Ltd
- Allergan Aesthetics Holistic Beauty Global Research. REF-148616. January 2026.
- Allergan Aesthetics Holistic Beauty Global Research. REF-148616. January 2026.
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