NORTH CHICAGO, Ill.,
July 9, 2020 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today announced
that the U.S. Food and Drug Administration (FDA) approved a
supplemental Biologics License Application (sBLA) that supports
expanded use of BOTOX® for the treatment of spasticity
in pediatric patients 2 years of age and older, including those
with lower limb spasticity caused by cerebral palsy.
This label expansion is based on Allergan and another
manufacturer selectively waiving orphan exclusivity marketing
rights each company held for the use of their respective
neurotoxins in the treatment of pediatric patients with spasticity
caused by cerebral palsy. BOTOX® was first approved in
June 2019 for the treatment of
pediatric patients with upper limb spasticity and in October 2019 for the treatment of pediatric
patients with lower limb spasticity, excluding spasticity caused by
cerebral palsy. BOTOX® has not been shown to improve
upper extremity functional abilities, or range of motion at a joint
affected by a fixed contracture.
Spasticity is a debilitating neurological condition involving
muscle stiffness that can result in tight muscles in the upper and
lower limbs. The severity can range from mild to severe, often
interfering with normal muscular movement and function. This can
result in delayed or impaired motor development, as well as
difficulty with posture and positioning. Common causes of
spasticity in children include cerebral palsy, traumatic brain
injury, multiple sclerosis, spinal cord injury, and stroke.
"Cerebral palsy is the most common cause of pediatric
spasticity, which can have a profound impact on a child's
development and quality of life. With its established safety and
efficacy profile, we are pleased that BOTOX® can now
more broadly support physicians treating pediatric spasticity,"
said Mitchell F. Brin, M.D., Senior
Vice President, Chief Scientific Officer, BOTOX® &
Neurotoxins, AbbVie. "Building upon our 30 years of research
and development efforts with BOTOX®, our commitment to
neurotoxin innovation continues, and it is particularly rewarding
to bring forth new treatments to advance care for pediatric
patients."
The safety and efficacy of BOTOX® as treatment for
lower limb spasticity for pediatric patients is supported by a
Phase 3 study with more than 300 patients two to 17 years of age
with lower limb spasticity because of cerebral palsy. These trials
included a 12-week, double-blind study and a one-year open-label
extension study.
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.1 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, a strong need to
urinate right away, and urinating often 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 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
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).
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 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 post-injection 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:
- Data on file, Allergan; BOTOX® Worldwide Marketing
Authorization Status; BOTOX® Prescribing
Information
View original
content:http://www.prnewswire.com/news-releases/fda-approves-expanded-botox-onabotulinumtoxina-label-for-the-treatment-of-pediatric-patients-with-spasticity-301091264.html
SOURCE AbbVie