NORTH CHICAGO, Ill.,
Feb. 10, 2021 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today announced
that the U.S. Food and Drug Administration (FDA) has approved
BOTOX® for the treatment of detrusor (bladder muscle)
overactivity associated with a neurologic condition in pediatric
patients 5 years of age and older who have an inadequate response
to or are intolerant of anticholinergic medication.
Neurogenic detrusor overactivity occurs when the spinal cord and
bladder are not able to communicate effectively, which can occur
with neurologic conditions such as spina bifida and spinal cord
injuries. As a result, the bladder muscle involuntarily contracts,
increasing the pressure in the bladder and reducing the bladder
capacity, which can cause the individual to leak urine frequently
and unexpectedly. Elevated bladder pressure can also lead to
bladder and kidney damage over time.
"BOTOX® is the first neurotoxin approved for use
in treating neurogenic detrusor overactivity in children who are
not adequately managed with anticholinergic medication. While
always satisfying to bring forth new indications, it is
particularly rewarding when we can help advance care for pediatric
patients with BOTOX®," said Mitchell F. Brin, M.D., Senior Vice President,
Chief Scientific Officer, BOTOX® & Neurotoxins,
AbbVie. "This milestone marks the 12th approved
therapeutic indication for BOTOX®, adding another
approved use to the pediatric portfolio. Building upon our 30-year
heritage in BOTOX® research and development, we remain
steadfast in our pursuit of neurotoxin innovation to address unmet
medical needs across therapeutic areas."
The FDA approval is based on data from a randomized,
double-blind Phase 3 study evaluating the safety and efficacy of
BOTOX® in more than 100 pediatric patients with
neurogenic detrusor overactivity and a long-term extension study.
Results from the Phase 3 study demonstrated that intradetrusor
administration of BOTOX® 200 Units (not to exceed 6U/kg)
reduced daytime urinary incontinence episodes, the study's primary
endpoint, as well as lowered maximum bladder pressure and increased
bladder capacity at week 6 (primary timepoint). The most common
adverse reaction in the studies were bacteriuria (20%), urinary
tract infection (7%), leukocyturia (7%), and hematuria (3%).
"Many children with underlying neurologic conditions may
experience bladder and kidney damage over time, which underscores
the importance of treatment. When caring for pediatric patients
with neurogenic detrusor overactivity, we strive to reduce bladder
pressure and increase the bladder's capacity. Previously, treatment
options were limited primarily to anticholinergic medicines, where
long-term use needs to be considered carefully, in addition to
surgery," said Paul F. Austin, M.D.,
FAAP, Chief of Pediatric Urology at Texas Children's Hospital and
Professor of Urology at Baylor College of
Medicine. "Effectively managing neurogenic detrusor
overactivity requires ongoing care, and there has been a high unmet
need for alternative treatments. With its proven safety and
efficacy profile, BOTOX® offers a new treatment option
for pediatric patients who are not adequately managed
by anticholinergics."
There are several causes of neurogenic detrusor overactivity in
children, such as transverse myelitis, spinal cord injury, and
spina bifida, the latter of which is the most common and affects
1,500-2,000 of the more than 4 million babies born in the United States each year.1 More
than 90% of those living with spina bifida experience urinary
symptoms.2,3,4,5
Allergan is committed to providing resources and services, such
as the BOTOX® Savings Program, to help ensure
BOTOX® is accessible and affordable to patients.
About BOTOX®
BOTOX® is one of
the most widely researched medications in the world, with a proven
history as a therapeutic agent.6 First approved by the
FDA in 1989 for two rare eye muscle disorders – blepharospasm and
strabismus in adults, BOTOX® was the world's first
approved botulinum toxin type A treatment. Today, BOTOX®
is FDA-approved for 12 therapeutic indications, including Chronic
Migraine, overactive bladder, leakage of urine (incontinence) due
to overactive bladder caused by a neurologic condition in adults,
cervical dystonia, spasticity, severe underarm sweating (axillary
hyperhidrosis), and pediatric detrusor overactivity associated with
a neurologic condition. Backed by strong science and continuous
innovation, BOTOX® proudly embraces its past while
boldly looking to the future.
BOTOX® (onabotulinumtoxinA) Important
Information
Indications
BOTOX® is a prescription
medicine that is injected into muscles and used:
- To treat overactive bladder symptoms such as a strong need to
urinate with leaking or wetting accidents (urge urinary
incontinence), a strong need to urinate right away (urgency), and
urinating often (frequency) in adults 18 years and older when
another type of medicine (anticholinergic) does not work well
enough or cannot be taken
- To treat leakage of urine (incontinence) in adults 18 years and
older with overactive bladder caused by a neurologic disease who
still have leakage or cannot tolerate the side effects after trying
an anticholinergic medication
- To treat overactive bladder due to a neurologic disease in
children 5 years of age and older when another type of medicine
(anticholinergic) does not work well enough or cannot be taken
- To prevent headaches in adults with Chronic Migraine who have
15 or more days each month with headache lasting 4 or more hours
each day in people 18 years or older
- To treat increased muscle stiffness in people 2 years of age
and older with spasticity
- To treat the abnormal head position and neck pain that happens
with Cervical Dystonia (CD) in people 16 years and older
- To treat certain types of eye muscle problems (Strabismus) or
abnormal spasm of the eyelids (Blepharospasm) in people 12 years of
age and older
BOTOX® is also injected into the skin to treat the
symptoms of severe underarm sweating (severe primary axillary
hyperhidrosis) when medicines used on the skin (topical) do not
work well enough in people 18 years and older.
It is not known whether BOTOX® is safe and effective
to prevent headaches in patients with migraine who have 14 or fewer
headache days each month (episodic migraine).
BOTOX® has not been shown to help people perform
task-specific functions with their upper limbs or increase movement
in joints that are permanently fixed in position by stiff
muscles.
It is not known whether BOTOX® is safe and effective
for severe sweating anywhere other than your armpits.
IMPORTANT SAFETY INFORMATION
BOTOX®
may cause serious side effects that can be life threatening. Get
medical help right away if you have any of these problems any time
(hours to weeks) after injection of
BOTOX®:
- Problems swallowing, speaking, or breathing, due to
weakening of associated muscles, can be severe and result in loss
of life. You are at the highest risk if these problems are
pre-existing before injection. Swallowing problems may last for
several months
- Spread of toxin effects. The effect of botulinum toxin
may affect areas away from the injection site and cause serious
symptoms including: loss of strength and all-over muscle weakness,
double vision, blurred vision and drooping eyelids, hoarseness or
change or loss of voice, trouble saying words clearly, loss of
bladder control, trouble breathing, and trouble swallowing
There has not been a confirmed serious case of spread of toxin
effect away from the injection site when BOTOX® has been
used at the recommended dose to treat Chronic Migraine, severe
underarm sweating, Blepharospasm, or Strabismus.
BOTOX® may cause loss of strength or general muscle
weakness, vision problems, or dizziness within hours to weeks of
taking BOTOX®. If this happens, do not drive a car,
operate machinery, or do other dangerous activities.
Do not receive BOTOX® if you: are
allergic to any of the ingredients in BOTOX® (see
Medication Guide for ingredients); had an allergic reaction to any
other botulinum toxin product such as Myobloc®
(rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or
Xeomin® (incobotulinumtoxinA); have a skin infection at
the planned injection site.
Do not receive BOTOX® for the treatment of
urinary incontinence if you: have a urinary tract infection
(UTI) or cannot empty your bladder on your own and are not
routinely catheterizing. Due to the risk of urinary retention (not
being able to empty the bladder), only patients who are willing and
able to initiate catheterization post treatment, if required,
should be considered for treatment.
Patients treated for overactive bladder:
In clinical
trials, 36 of the 552 patients had to self-catheterize for urinary
retention following treatment with BOTOX® compared to 2
of the 542 treated with placebo. The median duration of
postinjection catheterization for these patients treated with
BOTOX® 100 Units (n = 36) was 63 days (minimum 1 day to
maximum 214 days) as compared to a median duration of 11 days
(minimum 3 days to maximum 18 days) for patients receiving placebo
(n = 2). Patients with diabetes mellitus treated with
BOTOX® were more likely to develop urinary retention
than nondiabetics.
Adult Patients treated for overactive bladder due to
neurologic disease:
In clinical trials, 30.6% of patients
(33/108) who were not using clean intermittent catheterization
(CIC) prior to injection, required catheterization for urinary
retention following treatment with BOTOX® 200 Units as
compared to 6.7% of patients (7/104) treated with placebo. The
median duration of postinjection catheterization for these patients
treated with BOTOX® 200 Units (n = 33) was 289 days
(minimum 1 day to maximum 530 days) as compared to a median
duration of 358 days (minimum 2 days to maximum 379 days) for
patients receiving placebo (n = 7). Among patients not using CIC at
baseline, those with MS were more likely to require CIC post
injection than those with SCI.
The dose of BOTOX® is not the same as, or
comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been
reported, including itching, rash, red itchy welts, wheezing,
asthma symptoms, dizziness, or feeling faint. Get medical help
right away if you experience symptoms; further injection of
BOTOX® should be discontinued.
Tell your doctor about all your muscle or nerve
conditions, such as ALS or Lou
Gehrig's disease, myasthenia gravis, or Lambert-Eaton
syndrome, as you may be at increased risk of serious side effects,
including difficulty swallowing and difficulty breathing from
typical doses of BOTOX®.
Tell your doctor if you have any breathing-related
problems. Your doctor may monitor you for breathing problems
during treatment with BOTOX® for spasticity or for
detrusor overactivity associated with a neurologic condition. The
risk of developing lung disease in patients with reduced lung
function is increased in patients receiving BOTOX®.
Cornea problems have been reported. Cornea (surface of
the eye) problems have been reported in some people receiving
BOTOX® for their Blepharospasm, especially in people
with certain nerve disorders. BOTOX® may cause the
eyelids to blink less, which could lead to the surface of the eye
being exposed to air more than is usual. Tell your doctor if you
experience any problems with your eyes while receiving
BOTOX®. Your doctor may treat your eyes with drops,
ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding
behind the eyeball has been reported in some people receiving
BOTOX® for their Strabismus. Tell your doctor if you
notice any new visual problems while receiving
BOTOX®.
Bronchitis and upper respiratory tract infections (common
colds) have been reported. Bronchitis was reported more
frequently in adults receiving BOTOX® for upper limb
spasticity. Upper respiratory infections were also reported more
frequently in adults with prior breathing-related problems with
spasticity. In pediatric patients treated with BOTOX®
for upper limb spasticity, upper respiratory tract infections were
reported more frequently. In pediatric patients treated with
BOTOX® for lower limb spasticity, upper respiratory
tract infections were not reported more frequently than
placebo.
Autonomic dysreflexia in patients
treated for overactive bladder due to neurologic disease.
Autonomic dysreflexia associated with intradetrusor injections of
BOTOX® could occur in patients treated for detrusor
overactivity associated with a neurologic condition and may require
prompt medical therapy. In clinical trials, the incidence of
autonomic dysreflexia was greater in adult patients treated with
BOTOX® 200 Units compared with placebo (1.5% versus
0.4%, respectively).
Tell your doctor about all your medical conditions, including
if you: have or have had bleeding problems; have plans to have
surgery; had surgery on your face; weakness of forehead muscles;
trouble raising your eyebrows; drooping eyelids; any other abnormal
facial change; have symptoms of a urinary tract infection (UTI) and
are being treated for urinary incontinence (symptoms of a urinary
tract infection may include pain or burning with urination,
frequent urination, or fever); have problems emptying your bladder
on your own and are being treated for urinary incontinence; are
pregnant or plan to become pregnant (it is not known if
BOTOX® can harm your unborn baby); are breastfeeding or
plan to (it is not known if BOTOX® passes into breast
milk).
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. Using BOTOX® with certain other
medicines may cause serious side effects. Do not start any new
medicines until you have told your doctor that you have received
BOTOX® in the past.
Tell your doctor if you received any other botulinum toxin
product in the last 4 months; have received injections of botulinum
toxin such as Myobloc®,
Dysport®, or Xeomin® in the
past (tell your doctor exactly which product you received); have
recently received an antibiotic by injection; take muscle
relaxants; take an allergy or cold medicine; take a sleep medicine;
take aspirin-like products or blood thinners.
Other side effects of BOTOX® include:
dry mouth, discomfort or pain at the injection site, tiredness,
headache, neck pain, eye problems: double vision, blurred vision,
decreased eyesight, drooping eyelids, swelling of your eyelids, dry
eyes; drooping eyebrows; and upper respiratory tract infection. In
adults being treated for urinary incontinence other side effects
include: urinary tract infection, painful urination, and/or
inability to empty your bladder on your own. If you have difficulty
fully emptying your bladder after receiving BOTOX®, you
may need to use disposable self-catheters to empty your bladder up
to a few times each day until your bladder is able to start
emptying again. In children being treated for urinary incontinence
other side effects include: urinary tract infection and bacteria in
the urine.
For more information refer to the Medication Guide or talk with
your doctor.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Please see BOTOX® full
Product Information, including Boxed Warning
and Medication Guide.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
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, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @AbbVie on Twitter,
Facebook, Instagram, YouTube and LinkedIn.
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, among
others, 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 indicated in the forward-looking statements.
Such risks and uncertainties include, but are not limited to, the
failure to realize the expected benefits of AbbVie's acquisition of
Allergan or to promptly and effectively integrate Allergan's
business, 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 2019 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 to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
References:
- National Institute of Neurological Disorders and Stroke. Spina
Bifida Fact Sheet. Accessed online 5/6/2020 and available
from: https://www.ninds.nih.gov/disorders/patient-caregiver-education/fact- sheets/spina-bifida-fact-sheet.
- Hascoet J, Manunta A, Brochard C, Arnaud A, Damphousse M,
Menard H, et al. Outcomes of intra- detrusor injections of
botulinum toxin in patients with spina bifida: A systematic
review. Neurourology and
Urodynamics. 2017;36(3):557-564.
- Pannek J, Blok B, Castro-Diaz D, Del Popolo G, Kramer G,
Radziszewski P, et. al. Guidelines on neurogenic lower urinary
tract dysfunction. European Association of Urology, 2013.
Available from: https://uroweb.org/wp-content/uploads/20_Neurogenic-LUTD_LR.pdf.
- Shin M, Besser LM, Siffel C, Kucik JE, Shaw GM, Lu C, Correa A;
Congenital Anomaly Multistate Prevalence and Survival
Collaborative. Prevalence of spina bifida among children and
adolescents in 10 regions in the
United States. Pediatrics. 2010;126(2):274-279.
- Ouyang L, Grosse SD, Armour BS, Waitzman NJ. Health care
expenditures of children and adults with spina bifida in a
privately insured U.S. population. Birth Defects Research Part A,
Clinical and Molecular
Teratology. 2007;79(7):552-558.
- Data on file, Allergan; BOTOX® Worldwide Marketing
Authorization Status; BOTOX® Prescribing Information.
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