NORTH CHICAGO, Ill.,
June 22, 2020 /PRNewswire/ --
Allergan, an AbbVie (NYSE: ABBV) company, today announced that the
U.S. Food and Drug Administration (FDA) has accepted the company's
supplemental biologics license application (sBLA) to expand the
BOTOX® prescribing information for the treatment of
signs and symptoms of detrusor (bladder muscle) overactivity
associated with an underlying neurologic condition (e.g., spina
bifida, spinal cord injuries) in pediatric patients (5 -17 years of
age) who have an inadequate response to, or are intolerant of, or
for any reason unwilling to continue anticholinergic
medication.
The sBLA 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. The Prescription
Drug User Fee Act date is expected to be in the first quarter of
2021 following a standard 10-month review.
"The FDA acceptance of this application underscores our ongoing
commitment to pursuing the full potential of BOTOX® to
serve patients across a wide spectrum of diseases and clinical
needs," said Mitchell F. Brin, M.D.,
Senior Vice President, Chief Scientific Officer, BOTOX®
& Neurotoxins, AbbVie. "Children living with neurogenic
detrusor overactivity currently have limited options when they fail
anticholinergic medications and prior to surgical intervention. If
approved, BOTOX® will be the first neurotoxin treatment
approved for use in treating detrusor overactivity in pediatric
patients with an underlying neurologic condition who are not
adequately managed by anticholinergic medications."
Neurogenic detrusor overactivity results from the inability of
the spinal cord and bladder to communicate effectively. As a
result, the bladder muscle (detrusor) involuntarily contracts,
increasing the pressure in the bladder and reducing the bladder
capacity, which can cause the individual to leak urine frequently
and unexpectedly. If not adequately managed with clean intermittent
catheterization and anticholinergic drugs, this condition may
require augmentation cystoplasty (an extensive surgical procedure
in which the bladder is enlarged using a section of the patient's
intestine) to prevent renal damage.
There are a number of causes of neurogenic detrusor overactivity
in children, such as transverse myelitis, spinal cord injury, and
spina bifida, 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
"Over time, many pediatric patients with underlying neurologic
conditions experience bladder and kidney damage, and treatment is
critical," 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. "Current treatment options often include
anticholinergic medications, where long-term use needs to be
considered carefully, in addition to surgery. The favorable
BOTOX® clinical results for the treatment of pediatric
patients with neurogenic detrusor activity are promising as we look
to address unmet and ongoing needs in children and
adolescents."
BOTOX® is the first and only neurotoxin approved for
the treatment of leakage of urine (incontinence) due to overactive
bladder caused by a neurologic condition in adults who still have
leakage or cannot tolerate the side effects after trying an
anticholinergic medication. BOTOX® temporarily reduces
muscle contractions by blocking the transmission of nerve impulses
to the muscle, in this case, the bladder muscle, by selectively
preventing the release of the neurotransmitter acetylcholine at the
neuromuscular junction.
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 11 therapeutic indications, including Chronic
Migraine, overactive bladder, leakage of urine (incontinence) due
to overactive bladder caused by a neurologic condition, cervical
dystonia, spasticity, and severe underarm sweating (axillary
hyperhidrosis). 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 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 elbow, wrist, finger,
and thumb muscles in people 18 years and older with upper limb
spasticity
- To treat increased muscle stiffness in ankle and toe muscles in
people 18 years and older with lower limb spasticity
- To treat increased muscle stiffness in children 2 to 17 years
of age with upper limb spasticity
- To treat increased muscle stiffness in children 2 to 17 years
of age with lower limb spasticity, excluding spasticity caused by
cerebral palsy
- 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
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 or effective
to prevent headaches in patients with migraine who have 14 or fewer
headache days each month (episodic migraine).
It is not known whether BOTOX® is safe or effective
to treat increased stiffness in upper limb muscles other than those
in the elbow, wrist, fingers, and thumb, or in lower limb muscles
other than those in the ankle and toes in people 18 years and
older. 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 or effective
for other types of muscle spasms or 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.
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, or 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 your 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 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 people
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.
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,
competition from other products, challenges to intellectual
property, 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. 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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