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- 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, today 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.
About Glabellar Lines
Glabellar lines are 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
Allergan Aesthetics, an AbbVie company, develops, manufactures and markets 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 (formerly Twitter) 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.
| Contacts: Allergan Aesthetics Media: AbbVie Investors: Liz Shea FOOTNOTES * Survey conducted for Allergan Aesthetics. Online interviews conducted in December 2024 in population-representative samples from Australia (N=3,808), Brazil (N=4,226), China (N=N/A), Canada (N=4,054), UK (N=4,027), Japan (N=4,170) and Saudi Arabia (N=2,928).1 REFERENCES
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SOURCE AbbVie
