Allergan Aesthetics Receives Positive CHMP Opinion for Boey® (TrenibotulinumtoxinE) for the Temporary Improvement of Moderate to Severe Glabellar Lines in Adults
Rhea-AI Summary
Allergan Aesthetics (NYSE: ABBV) received a positive CHMP opinion for Boey (trenibotulinumtoxinE) to temporarily improve moderate to severe glabellar lines in adults in 30 EU/EEA markets. Recommendations follow two Phase 3 trials meeting all endpoints, showing onset from 8 hours and 2–3 weeks’ efficacy, with adverse events similar to placebo.
Positive
- Positive CHMP opinion for Boey covering 30 EU and EEA markets
- Phase 3 trials met all primary and secondary efficacy endpoints
- Onset of effect observed as early as 8 hours post-treatment
- Efficacy duration of 2–3 weeks in Phase 3 studies
- Adverse events profile reported as similar to placebo
- Marketing submissions under review in multiple additional countries
Negative
- European Commission marketing authorization decision still pending before EU launch
News Market Reaction – ABBV
In the May 22 session, ABBV gained 0.56%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 06 | Conference participation | Neutral | -0.5% | Announcement of AbbVie fireside chat at a major healthcare conference. |
| May 05 | IBD data update | Positive | -1.0% | Long-term data for risankizumab and upadacitinib in IBD at DDW 2026. |
| May 05 | Early-stage IBD data | Positive | -1.0% | Phase 1 and preclinical data for oral NIM-1324 showing target engagement and safety. |
| Apr 30 | Aesthetics initiative | Neutral | +3.6% | Allergan Aesthetics charitable referral campaign tied to Skin Cancer Awareness Month. |
| Apr 29 | Q1 2026 earnings | Positive | +3.1% | Q1 revenue growth, raised 2026 EPS guidance, and multiple portfolio/regulatory updates. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent positive R&D and earnings news generally aligned with price gains, while some scientific data updates saw short-term divergences.
Over the past month, AbbVie reported Q1 2026 results with net revenues of $15.002B and raised full-year EPS guidance, which coincided with a positive price reaction. Aesthetics initiatives and IBD data presentations at DDW 2026 were followed by mixed, often slightly negative, moves. Conference appearances also saw modest declines. Against this backdrop, the positive CHMP opinion for Boey® extends AbbVie’s aesthetics narrative in Europe after prior manufacturing setbacks noted in earlier filings.
Key Terms
chmp regulatory
european medicines agency regulatory
phase 3 medical
treatment-emergent adverse events medical
placebo medical
marketing authorization regulatory
centralized procedure regulatory
botulinum neurotoxin medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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
"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 REFERENCES
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