BOTOX® Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands)

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Oct 18, 2024, 19:44 ET

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 Adults^1-5
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 Adults^1-5

IRVINE, Calif., Oct. 18, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of BOTOX^® Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults.¹ BOTOX^® Cosmetic is the first and only product with four aesthetic indication areas: forehead lines, frown lines, crow's feet lines, and now platysma bands, making it the first product of its kind to go beyond the face.^1-5

"Research shows millions of consumers in the U.S. are extremely or very bothered by their platysma bands.⁶* Until now, treatment options have been limited and with this approval, there is a nonsurgical, injectable option to temporarily improve the look of vertical bands connecting the jaw and neck," said Darin J. Messina, Ph.D., Senior Vice President, Aesthetics R&D at Allergan Aesthetics. "This fourth indication for BOTOX^® Cosmetic represents true innovation. We're excited to open new doors for patients and providers, helping them to achieve their aesthetic goals."

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 (65% and 62%) reported being "Very Satisfied" or "Satisfied" (top two out of five responses) with the appearance of their neck and jawline definition 14 days after treatment with a dose of 26, 31, or 36 units of BOTOX^® Cosmetic, compared to 12% in both studies with placebo.

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 3.8% indicated they were "Very" or "Extremely Bothered" (top two out of five responses) by their platysma bands.⁶

^†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: 32% (n=63) vs 2% placebo (n=4) in Study 1; 31% (n=64) vs 0% placebo (n=0) in Study 2.¹

^‡Payment options through Cherry Technologies, Inc. are issued by the following lending partners: www.withcherry.com/lending-partners/. Term length, approval amount, 0% APR and other promotional rates are subject to eligibility. See www.withcherry.com/terms for details. Iowa only: Borrowers are subject to Iowa state specific underwriting criteria. APR for all Iowa borrowers is capped at 20.99%.

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 (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).

The most frequently reported adverse reaction following injection of BOTOX^® Cosmetic for lateral canthal lines was eyelid edema (1%).

The most frequently reported adverse reactions following injection of BOTOX^® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).

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.

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