DUBLIN, June 21, 2019 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced that the U.S. Food and Drug
Administration (FDA) approved the company's supplemental biologics
application (sBLA) for BOTOX® for the treatment of
pediatric patients (2 to 17 years of age) with upper limb
spasticity. BOTOX® was granted a six-month Priority
Review by the FDA, which is typically granted to therapies that if
approved, could offer significant improvements in safety and
effectiveness when compared to current standard of care. The FDA is
also reviewing an additional sBLA for the use of BOTOX®
to treat pediatric patients with lower limb spasticity, with a
decision expected in the fourth quarter of this year.
Damage to the brain and spine can result in spasticity, which is
often observed as muscle tightness and stiffness in the upper and
lower limbs. Upper limb spasticity can interfere with movement at
the joints of the upper limb and its severity can range from
mild to severe muscle stiffness. Common causes of spasticity
in children include cerebral palsy, traumatic brain injury,
multiple sclerosis, spinal cord injury, and stroke, which is a
group of disorders affecting one's ability to move and maintain
balance and posture.
"Watching a child suffering with any degree of upper limb
spasticity is very difficult," said David
Nicholson, Chief Research and Development Officer, Allergan.
"This FDA approval is special to all of us at Allergan because we
can now provide children and their caregivers an advancement in
pediatric care with BOTOX®. This milestone underscores
our constant focus on innovation and builds on our 30-years of
research and development efforts with BOTOX® since FDA
approval of blepharospasm and strabismus in 1989. We also look
forward to the FDA's decision on pediatric lower limb spasticity
and continuing to serve our patients globally."
The FDA approval is based on data from two Phase 3 studies
evaluating the safety and efficacy of BOTOX® in over 200
pediatric patients with upper limb spasticity. These trials
included a 12-week, double-blind study and a one-year
open-label extension study.
The approved recommended dose per treatment session is 3 Units
per kilogram to 6 Units per kilogram divided among affected muscles
of the upper limb. The total dose in pediatric patients should not
exceed 8 Units per kilogram body weight or 300 Units, whichever is
lower, in a 3-month interval. Treatment with BOTOX® is
not meant to replace existing physical therapy or other
rehabilitation that may have been prescribed.
"Pediatric upper limb spasticity is a significant concern and
can negatively impact a child's development and quality of life,"
said Mark Gormley, Jr. M.D.,
Pediatric Rehabilitation Medicine Specialist, Gillette Children's
Specialty Healthcare-St. Paul. "Because spasticity is particularly
debilitating to growing children, it requires ongoing care.
BOTOX® has a well-established safety and efficacy
profile and I believe it will be an important treatment option in
helping successfully manage upper limb spasticity in children and
adolescents."
Allergan is committed to providing resources and services, such
as the BOTOX® Savings Program, to help ensure
BOTOX® is accessible and affordable to patients.
Over the past 30 years, more than 100 million vials of
BOTOX® and BOTOX® Cosmetic
(onabotulinumtoxinA) have been distributed worldwide. With more
than 3,700 articles on BOTOX® and
BOTOX® Cosmetic published in scientific and medical
journals, BOTOX® neurotoxin is one of the most
widely researched medicines in the world.
BOTOX® (onabotulinumtoxinA)
Important Information
Indications
BOTOX® is
a prescription medicine that is injected into muscles
and used:
- to treat increased muscle stiffness in children 2 to 17 years
of age with upper limb spasticity
- to treat certain types of eye muscle problems (strabismus) or
abnormal spasm of the eyelids (blepharospasm) in people 12 years
and older
Treatment with BOTOX® in children 2 to
17 years of age with upper limb spasticity is not
meant to replace existing physical
therapy or other rehabilitation that may have
been prescribed.
It is not known whether BOTOX® is
safe or effective for other types of muscle spasms.
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 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.
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®.
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. In pediatric
patients treated with BOTOX® for upper limb spasticity,
upper respiratory tract infections were reported more
frequently.
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; 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.
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.
Please see BOTOX® Cosmetic full
Product Information including Boxed Warning and Medication
Guide.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical
leader focused on developing, manufacturing and commercializing
branded pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located in
approximately 100 countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives every day.
For more information, visit Allergan's website
at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective on existing trends and
information as of the date of this release. Actual results may
differ materially from Allergan's current expectations depending
upon a number of factors affecting Allergan's business. These
factors include, among others, the difficulty of predicting the
timing or outcome of FDA approvals or actions, if any; the impact
of competitive products and pricing; market acceptance of and
continued demand for Allergan's products; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated
with divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Annual Report on Form 10-K
for the year ended December 31, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
March 31, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
CONTACTS:
Allergan:
Investors:
Manisha Narasimhan, PhD
(862) 261-7162
Christine
Chiou
(862) 261-7396
Media:
Amy
Rose
(862) 289-3072
Lisa Kim
(714) 246-3843
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SOURCE Allergan plc