BOTOX® Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands)
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced FDA approval of BOTOX® Cosmetic for temporary improvement of moderate to severe platysma bands in adults. This marks BOTOX® Cosmetic's fourth aesthetic indication, making it the first product to go beyond the face. The approval offers a nonsurgical, injectable option for treating vertical bands connecting the jaw and neck.
In Phase III clinical studies, BOTOX® Cosmetic demonstrated significant improvement in platysma band appearance compared to placebo. The FDA-approved doses are 26, 31, or 36 units based on severity. A majority of patients reported being satisfied with their neck and jawline definition after treatment.
Patients can learn more and enroll in Allē, Allergan Aesthetics' loyalty rewards program, which offers points on various treatments and flexible payment options.
Allergan Aesthetics, un'azienda di AbbVie (NYSE: ABBV), ha annunciato l'approvazione da parte della FDA di BOTOX® Cosmetic per il miglioramento temporaneo delle moderate a severe fascie platismali negli adulti. Questo segna la quarta indicazione estetica di BOTOX® Cosmetic, rendendolo il primo prodotto a estendersi oltre il viso. L'approvazione offre un opzione iniettabile non chirurgica per il trattamento delle bande verticali che collegano la mandibola e il collo.
Negli studi clinici di Fase III, BOTOX® Cosmetic ha mostrato un miglioramento significativo nell'aspetto delle fascie platismali rispetto al placebo. Le dosi approvate dalla FDA sono 26, 31 o 36 unità in base alla gravità. La maggior parte dei pazienti ha riferito di essere soddisfatta della definizione del collo e della mandibola dopo il trattamento.
I pazienti possono saperne di più e iscriversi a Allē, il programma di premi fedeltà di Allergan Aesthetics, che offre punti su vari trattamenti e opzioni di pagamento flessibili.
Allergan Aesthetics, una empresa de AbbVie (NYSE: ABBV), anunció la aprobación por parte de la FDA de BOTOX® Cosmetic para la mejora temporal de las bandas platismales moderadas a severas en adultos. Esto marca la cuarta indicación estética de BOTOX® Cosmetic, convirtiéndose en el primer producto que va más allá de la cara. La aprobación ofrece una opción inyectable no quirúrgica para el tratamiento de bandas verticales que conectan la mandíbula y el cuello.
En estudios clínicos de Fase III, BOTOX® Cosmetic demostró una mejora significativa en la apariencia de las bandas platismales en comparación con el placebo. Las dosis aprobadas por la FDA son de 26, 31 o 36 unidades, según la gravedad. La mayoría de los pacientes informó estar satisfecha con la definición de su cuello y mandíbula después del tratamiento.
Los pacientes pueden obtener más información e inscribirse en Allē, el programa de recompensas de lealtad de Allergan Aesthetics, que ofrece puntos en varios tratamientos y opciones de pago flexibles.
알레르간 미적 외과(굉장히 아름다운 외모) 는 AbbVie (NYSE: ABBV) 의 승인을 받았고 FDA는 BOTOX® Cosmetic을 성인의 중간에서 심한 플라티즘 밴드 일시적 개선을 위해 승인했습니다. 이는 BOTOX® Cosmetic의 네 번째 미적 적응증으로, 얼굴 이상으로 나아간 첫 번째 제품입니다. 이 승인은 턱과 목을 연결하는 수직 밴드를 치료하기 위한 비수술적 주사 옵션을 제공합니다.
3상 임상 연구에서 BOTOX® Cosmetic은 위약과 비교하여 플라티즘 밴드 외관의 유의미한 개선을 입증했습니다. FDA가 승인한 용량은 심각도에 따라 26, 31 또는 36유닛입니다. 대다수의 환자들이 치료 후 목과 턱선의 정의에 만족한다고 보고했습니다.
환자들은 Allē에 대해 더 알아보고, 알레르간 미적 외과의 충성도 보상 프로그램에 등록할 수 있습니다. 이 프로그램은 다양한 치료에 포인트와 유연한 지불 옵션을 제공합니다.
Allergan Aesthetics, une entreprise de AbbVie (NYSE: ABBV), a annoncé l'approbation de la FDA pour BOTOX® Cosmetic visant à améliorer temporairement les bandes platysma modérées à sévères chez les adultes. Cela marque la quatrième indication esthétique de BOTOX® Cosmetic, faisant de ce produit le premier à aller au-delà du visage. L'approbation offre une option injectable non chirurgicale pour traiter les bandes verticales reliant la mâchoire et le cou.
Dans le cadre des études cliniques de phase III, BOTOX® Cosmetic a démontré une amélioration significative de l'apparence des bandes platysma par rapport au placebo. Les doses approuvées par la FDA sont de 26, 31 ou 36 unités, en fonction de la gravité. Une majorité de patients a déclaré être satisfaite de la définition de son cou et de sa mâchoire après traitement.
Les patients peuvent en apprendre davantage et s'inscrire à Allē, le programme de récompenses de fidélité d'Allergan Aesthetics, qui offre des points sur divers traitements et des options de paiement flexibles.
Allergan Aesthetics, ein Unternehmen von AbbVie (NYSE: ABBV), hat die FDA-Zulassung von BOTOX® Cosmetic zur temporären Verbesserung von moderaten bis schweren Platysma-Bändern bei Erwachsenen bekannt gegeben. Dies ist die vierte ästhetische Indikation von BOTOX® Cosmetic, wodurch es das erste Produkt ist, das über das Gesicht hinausgeht. Die Genehmigung bietet eine nicht-chirurgische, injizierbare Option zur Behandlung von vertikalen Bändern, die Kiefer und Hals verbinden.
In Phase-III-Studien zeigte BOTOX® Cosmetic eine signifikante Verbesserung des Aussehens der Platysma-Bänder im Vergleich zu Placebo. Die von der FDA genehmigten Dosen betragen 26, 31 oder 36 Einheiten, je nach Schweregrad. Die Mehrheit der Patienten berichtete nach der Behandlung von der Zufriedenheit mit der Definition von Hals und Kieferlinie.
Patienten können mehr erfahren und sich bei Allē, dem Treueprogramm von Allergan Aesthetics, anmelden, das Punkte für verschiedene Behandlungen und flexible Zahlungsoptionen bietet.
- FDA approval for a new aesthetic indication (platysma bands)
- First and only product with four aesthetic indications
- Nonsurgical treatment option for a common aesthetic concern
- Positive clinical trial results showing significant improvement over placebo
- Majority of patients reported satisfaction with treatment results
- Expansion of Allē loyalty program to include more treatments and payment options
- Treatment effects are temporary, requiring repeat procedures
- to moderate to severe cases of platysma bands
Insights
The FDA approval of BOTOX® Cosmetic for platysma bands represents a significant expansion in the aesthetic market for AbbVie's Allergan Aesthetics division. This fourth indication makes BOTOX® the first and only neurotoxin approved for use beyond the face, potentially opening up a new revenue stream.
Key points:
- Addresses an unmet need in the
$16.5 billion global facial aesthetics market - Expands BOTOX®'s competitive advantage over rival neurotoxins
- Clinical trials showed
65% and62% patient satisfaction rates, significantly higher than placebo - Leverages existing brand recognition and distribution channels
This approval could drive increased sales and market share for BOTOX® Cosmetic, potentially boosting AbbVie's aesthetics segment revenue. However, the impact may be gradual as consumer awareness and adoption grow over time.
This FDA approval strengthens AbbVie's position in the high-margin aesthetics market, which has been a key growth driver since its
Financial implications:
- Potential for incremental revenue growth in the aesthetics segment
- Reinforces BOTOX®'s market leadership, protecting against competitive threats
- May support pricing power and profit margins in the aesthetics portfolio
- Aligns with AbbVie's strategy to diversify beyond immunology
While the immediate financial impact may be modest, this approval enhances AbbVie's long-term growth prospects in aesthetics. Investors should monitor adoption rates and sales trends in upcoming quarterly reports to gauge the success of this new indication.
- The Only Product of Its Kind Approved for Use in Four Aesthetic Indications: Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines, Frown Lines, Crow's Feet Lines, and Now Platysma Bands in Adults1-5
- With this Approval, BOTOX® Cosmetic is the First and Only Aesthetic Neurotoxin Product to Temporarily Improve the Appearance of Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) in Adults1-5
"Research shows millions of consumers in the
The platysma muscle is a thin muscle that covers the neck and extends over the lower face. When this muscle is contracted it can cause the appearance of bands on the neck, which can also create a less defined jawline. Treatment with BOTOX® Cosmetic works beneath the surface to temporarily reduce the underlying muscle activity and improves the appearance of the bands connecting the neck and jaw.1 By injecting along the jawline and the vertical bands connecting the jaw and neck with one of the FDA-approved doses of BOTOX® Cosmetic based on severity—26, 31, or 36 units—BOTOX® Cosmetic temporarily reduces underlying muscle activity.1 Patients are encouraged to speak to their licensed aesthetic specialist to determine if treatment is right for them.
"In my practice, the neck and lower face are always a standard part of my comprehensive aesthetic consultation. Many of my patients are often surprised by the significant impact that changes in these areas can have," said Dr. Terrence Keaney, board-certified dermatologist and pivotal clinical trial investigator. "With the approval of BOTOX® Cosmetic for the treatment of platysma bands, including precise injection patterns and dosing, I can now confidently offer my patients a treatment option that can help deliver the results they are looking to achieve."
In Phase III clinical studies, the primary endpoint was met, demonstrating statistical significance for the improvement in appearance of platysma bands from baseline with BOTOX® Cosmetic versus placebo (p<0.0001).† This measure was based on both investigator and subject assessment. All secondary endpoints were met, as measured by multiple validated, proprietary patient-reported outcome (PRO) instruments.1 For example, in two clinical studies, a majority of patients (
Patients interested in learning more about BOTOX® Cosmetic for platysma bands are encouraged to enroll in Allē, the Allergan Aesthetics loyalty rewards program. In serving more than seven million Members across ~30,000 practices to date, part of Allē's mission is to help educate consumers about aesthetic treatments and to simplify office operations for practices. From its inception, Allē has disrupted the aesthetics industry by offering the most robust rewards program. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 50 non-Allergan Aesthetics treatments and brands. By providing Members with information, tools, and incentives, and now with flexible ways to pay through Allē Payment Plans powered by Cherry‡, Allē empowers consumers along their treatment journey, making the next product purchase or treatment closer within reach.
To learn more about BOTOX® Cosmetic, visit www.botoxcosmetic.com and follow @botoxcosmetic on social media.
*Nine million based on 2021 U.S. Census Projections: calculated from 2021 total population projections from a survey of 15,295 participants of which
†Primary endpoint was a multi-component ≥ 2-grade improvement based on both Investigator and Subject assessments of Platysma Band Severity at maximum contraction at day 14:
‡Payment options through Cherry Technologies, Inc. are issued by the following lending partners: www.withcherry.com/lending-partners/. Term length, approval amount,
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 – immunology, oncology, neuroscience, and eye care – 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.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Moderate to severe lateral canthal lines associated with orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis activity
- Moderate to severe platysma bands associated with platysma muscle activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses. |
CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Equivalency Between Botulinum Toxin Products
The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. BOTOX® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX® Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Cardiovascular System
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease.
Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders
Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.
Dysphagia and Breathing Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Preexisting Conditions at the Injection Site
Use caution when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Dry Eye in Patients Treated With BOTOX® Cosmetic
There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (
The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (
The safety profile of BOTOX® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX® Cosmetic for other indications.
DRUG INTERACTIONS
Coadministration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.
Please see BOTOX® Cosmetic full Prescribing Information, including Boxed Warning and Medication Guide.
Reference:
- BOTOX® Cosmetic Prescribing Information, October 2024.
- Dysport® Prescribing Information, 2020.
- Xeomin® Prescribing Information, 2024.
- Jeuveau® Prescribing Information, 2020.
- Daxxify® Prescribing Information, 2022.
- Allergan Data on File. 2023 Aesthetic Market Sizing. 2023.
© 2024 AbbVie. All rights reserved. BOTOX Cosmetic and its designs are trademarks of Allergan Holdings France SAS, an AbbVie company, or its affiliates.
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SOURCE AbbVie
FAQ
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