- 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
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.
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
- Almukhtar RM and Fabi S. Plast Reconstr Surg.
2019;143:39e-48e.
- BOTOX® Cosmetic Prescribing Information,
November 2023.
- BOTOX® Prescribing Information, November 2023.
- Data on file, Allergan Aesthetics, October 29, 2020; Westport Manufacturing
Process.
- Data on file, Allergan, December 5,
2022; Number of Total Vials Produced at Westport.
- Data on file, Allergan Aesthetics, January 2023; Worldwide Marketing Authorization
Status.
- Masseter Global Assessment – Patient Assessment Quantitative
Report May 2021. Allergan Aesthetics
Primary Market Research performed by LRW.
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