DUBLIN, Oct. 24, 2019 /PRNewswire/ -- Allergan plc (NYSE:
AGN) today announced that the U.S. Food and Drug Administration
(FDA) approved the company's supplemental Biologics
License Application (sBLA) for BOTOX® for the
treatment of pediatric patients (2 to 17 years of age) with lower
limb spasticity, excluding spasticity caused by cerebral palsy
(CP). This marks the 11th BOTOX® therapeutic
indication, having been approved for pediatric upper limb
spasticity (ULS) earlier this year. Spasticity is a debilitating
neurological condition involving muscle stiffness that can result
in tight muscles in the upper and lower limbs, and can interfere
with movement. The severity can range from mild to severe
muscle stiffness.
"Lower limb spasticity can impact many aspects of a child's life
and have a drastic influence on their overall development and
quality of life," said David
Nicholson, Chief Research and Development Officer, Allergan.
"This milestone will continue to support and advance care for
children and their caregivers who may be struggling with lower limb
spasticity. Here at Allergan, we look forward to continuing to
highlight our unwavering attention to innovation and build on our
30-years of research and development efforts with
BOTOX®® since FDA approval of blepharospasm and
strabismus in 1989."
The FDA approval is based on a Phase 3 study evaluating the
safety and efficacy of BOTOX® in more than 300 pediatric
patients aged two to 17 years old being treated for lower limb
spasticity. While trial participants had cerebral palsy, the
approved indication excludes lower limb spasticity caused by
cerebral palsy due to marketing exclusivity by another company.
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 4 Units
per kilogram to 8 Units per kilogram divided among affected muscles
of the lower limb. The total dose per treatment session in
the lower limb should not exceed 8 Units per kilogram or 300 Units,
whichever is lower. When treating both lower limbs or upper and
lower limbs in combination, the total dose in pediatric patients
should not exceed 10 Units per kilogram body weight or 340
Units, whichever is lower, in a 3-month interval.
"Pediatric lower limb spasticity inhibits normal muscular
movement and function and can result in delayed or impaired motor
development, as well as difficulty with posture and positioning,"
said Mark Gormley, Jr. M.D.,
Pediatric Rehabilitation Medicine Specialist, Gillette Children's
Specialty Healthcare-St. Paul. "BOTOX® has a
well-established safety and efficacy profile, and supports children
and adolescents successfully manage both their upper and lower limb
spasticity."
Allergan is committed to providing resources and services, such
as the BOTOX® Savings Program, to help ensure
BOTOX® is accessible and affordable to
patients.
BOTOX® (onabotulinumtoxinA)
Important Information [UPDATE WITH FINAL APPROVED ISI]
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 increased muscle stiffness in children 2 to 17 years
of age with lower limb spasticity, excluding spasticity caused by
cerebral palsy
- to treat certain types of eye muscle problems (strabismus) or
abnormal spasm of the eyelids (blepharospasm) in people 12 years
and older
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®.
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. In pediatric patients treated with
BOTOX® for lower limb spasticity, upper respiratory
tract infection was not reported with an incidence greater than
placebo.
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.
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
June 30, 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
Media:
Lisa Brown
(862) 261-7320
Lisa Kim
(714) 246-3843
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