• BOTOX Cosmetic is the first neurotoxin approved in China for the treatment of masseter muscle prominence (MMP), the largest global market for MMP.

• Approval supported by well-established safety profile and robust clinical trials demonstrating BOTOX Cosmetic is effective in reducing the prominence of the masseter muscle.

• Allergan Aesthetics intends to develop onabotulinumtoxinA treatment for MMP in additional global markets and expand the use of BOTOX Cosmetic in the lower face.

IRVINE, Calif., Sept. 11, 2024 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced that BOTOX Cosmetic (onabotulinumtoxinA) is now available for the treatment of masseter muscle prominence (MMP) in China. The masseter is one of the muscles in the lower face involved in chewing, and prominence of the masseter muscle can result in a wide and square lower face shape1. BOTOX Cosmetic was recently approved for the temporary improvement in the appearance of marked to very marked MMP in adults by the China National Medical Product Administration (NMPA). BOTOX Cosmetic is the first neurotoxin approved in China for MMP and offers the established dosing, robust clinical evidence and physician training that comes with on-label treatment.

"Masseter prominence is among the top aesthetics concerns for my patients and the broader Asian population, and there is a significant unmet need for minimally invasive treatment options for patients interested in addressing their lower face shape," said Professor Sun Jiaming, lead clinical study investigator and Director of the Plastic Surgery Department of Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology. "The approval of BOTOX Cosmetic offers an effective option delivered in a single treatment dosed every six months that relaxes masseter muscles and help patients achieve a slimmer and more defined jawline."

In a Phase 3 clinical trial, subjects treated with BOTOX Cosmetic had 5.2mm greater average reduction of facial width as compared to subjects treated with placebo. Results typically lasted 6-9 months following BOTOX Cosmetic treatment. Improvement was also seen in all secondary endpoints, as measured by multiple proprietary patient-reported outcome (PRO) instruments assessing psychosocial impact, treatment expectations and treatment satisfaction from the subject perspective. Subjects treated with BOTOX Cosmetic had improved ratings in psychosocial impact (satisfaction with level of interaction in social situations), attractiveness, and confidence compared to subjects treated with placebo.

Treatment-emergent adverse events for BOTOX Cosmetic were mild or moderate and consistent with known pharmacological effects of BOTOX Cosmetic, which has a well-established safety profile throughout its 30-year history. No new safety signals were observed. The clinical study was conducted in multiple centers globally and nearly 90 percent (87.3%) of subjects identified as Asian.

"BOTOX Cosmetic for masseter muscle prominence is a key focus for our global R&D pipeline," said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "We are excited to be approved and launch first in China, one of our most important markets."

With over 150 million vials of BOTOX and BOTOX Cosmetic distributed worldwide2-6, the availability of BOTOX Cosmetic for MMP in China marks another important milestone for the global aesthetic brand that medical providers and patients know and trust. Beyond China, reduction of MMP is a highly desirable, yet undertreated, indication for patients across all age ranges worldwide who may prefer a narrower lower face shape.7 Those bothered by marked or very marked MMP are typically unaware of potential treatment options and very few receive treatment7. Additional regulatory applications for onabotulinumtoxinA treatment for MMP are planned globally. BOTOX Cosmetic is currently not approved by the U.S. Food and Drug Administration for MMP.

About Masseter Muscle Prominence
Masseter muscle prominence (MMP) is a benign condition where the masseter muscle along the jaw is enlarged and more noticeable1. This can cause the lower face to appear disproportionately wide and square, which may be an aesthetic concern for some people1. MMP can negatively impact self-perception of facial attractiveness and cause psychological distress1. MMP can be caused by heredity or overuse from activities like chewing gum, sports, clenching, or nocturnal bruxism1. It can be present in people of any age but adults between 20 and 40 are more likely to seek treatment1. Current treatment approaches are primarily surgical1 and BOTOX Cosmetic offers a minimally invasive option.

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

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 Interchangeability Between Botulinum Toxin Products
The potency units of BOTOX Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with 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 pre-existing 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 reactions occur, further injection of BOTOX Cosmetic should be discontinued and appropriate medical therapy immediately instituted. 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 pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.

Increased Risk of Clinically Significant Effects With Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. 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).

Dysphagia and Breathing Difficulties
Treatment with BOTOX and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing 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).

Pre-existing Conditions at the Injection Site
Caution should be used 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 an extremely 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), but if that risk actually exists, the risk of transmission would also be considered extremely 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%).

DRUG INTERACTIONS
Co-administration 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.

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

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 . 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, and changes to laws and regulations applicable to our industry. 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 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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.

References

1. Almukhtar RM and Fabi S. Plast Reconstr Surg. 2019;143:39e-48e.

2. BOTOX Cosmetic Prescribing Information, November 2023.

3. BOTOX Prescribing Information, November 2023.

4. Data on file, Allergan Aesthetics, October 29, 2020; Westport Manufacturing Process.

5. Data on file, Allergan, December 5, 2022; Number of Total Vials Produced at Westport.

6. Data on file, Allergan Aesthetics, January 2023; Worldwide Marketing Authorization Status.

7. Masseter Global Assessment – Patient Assessment Quantitative Report May 2021. Allergan Aesthetics Primary Market Research performed by LRW.

SOURCE  AbbVie