DUBLIN, Aug. 20, 2015 /PRNewswire/ -- Allergan plc
(NYSE: AGN), a leading global pharmaceutical company today
announced that the U.S. Food and Drug Administration (FDA) has
accepted the company's resubmission of its Supplemental Biologics
License Application (sBLA) for BOTOX® (onabotulinumtoxinA) for the
treatment of adults with lower limb (involving ankle and toe
muscles) spasticity in adults. A six-month review period has been
assigned for the sBLA. The Prescription Drug User Fee Act (PDUFA)
date is expected to be in the first quarter of 2016.
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"We have continued to work closely with the FDA to prepare our
resubmission and we are confident that the additional information
requested is addressed," said Mitchell F.
Brin, M.D., Senior Vice President Global Development and
Chief Scientific Officer, BOTOX®. "This FDA acceptance represents
our ongoing commitment to research and development, and efforts to
bring to market the first-approved focal therapy for lower limb
spasticity for physicians and patients."
The resubmission provides additional data from a double-blind,
placebo controlled study involving 468 patients with lower limb
spasticity.
In April 2015, the FDA approved an
expansion of the BOTOX® (onabotulinumtoxinA) label for the
treatment of adults with upper limb spasticity. The expanded label
now includes the addition of two thumb muscles: flexor pollicis
longus, a muscle in the forearm that flexes the thumb; and adductor
pollicis, a muscle in the hand that functions to adduct the thumb;
increasing the maximum dose from 360 to 400 units for the treatment
of upper limb spasticity. The FDA also approved an increase to the
maximum BOTOX® cumulative dose within three months from 360 to 400
units in adults treated for one or more indications.
INDICATION
BOTOX® (onabotulinumtoxinA) is
a prescription medicine that is injected into muscles and used to
treat increased muscle stiffness in elbow, wrist, finger, and thumb
muscles in people 18 years and older with upper limb
spasticity.
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 to treat increased stiffness
in lower-limb muscles. 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. Treatment with BOTOX® is not meant to replace your
existing physical therapy or other rehabilitation that your doctor
may have prescribed.
BOTOX® (onabotulinumtoxinA) IMPORTANT SAFETY
INFORMATION
BOTOX® may cause serious side effects that can be life
threatening. Call your doctor or 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 (dysphonia), trouble saying words clearly
(dysarthria), loss of bladder control, trouble breathing, trouble
swallowing. If this happens, do not drive a car, operate
machinery, or do other dangerous activities
Do not take 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. These reactions include itching, rash, red itchy
welts, wheezing, asthma symptoms, or dizziness or feeling faint.
Tell your doctor or get medical help right away if you experience
any such symptoms; further injection of BOTOX® should be
discontinued.
Tell your doctor about all your muscle or nerve
conditions such as amyotrophic lateral sclerosis (ALS or
Lou Gehrig's disease), myasthenia
gravis, or Lambert-Eaton syndrome, as you may be at increased risk
of serious side effects including severe dysphagia (difficulty
swallowing) and respiratory compromise (difficulty breathing) from
typical doses of BOTOX®.
Tell your doctor if you have any breathing-related
problems. Your doctor will want to monitor you for any
breathing problems during your treatment with BOTOX® for upper limb
spasticity. The risk of pulmonary effects in patients with
compromised respiratory status is increased in patients receiving
BOTOX®.
Bronchitis and upper respiratory tract infections (common
colds) have been reported. Bronchitis was reported more
frequently in people receiving BOTOX® for their upper limb
spasticity. Upper respiratory infections (common colds) were also
reported more frequently in people with prior breathing-related
problems.
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,
such as 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 breastfeed (it is not known if BOTOX®
passes into breast milk).
Tell your doctor about all the medicines you take,
including prescription and nonprescription medicines, vitamins, and
herbal products. 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.
Especially tell your doctor if you: have 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 (be sure your doctor
knows 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 anti-platelets
(aspirin-like products) or anti-coagulants (blood thinners).
Other side effects of BOTOX® include: dry mouth,
discomfort or pain at the injection site, tiredness, headache, neck
pain, and eye problems: double vision, blurred vision, decreased
eyesight, drooping eyelids, swelling of your eyelids, and dry
eyes.
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.
® marks owned by Allergan, Inc.
Myobloc® is a registered trademark of Solstice Neuroscience,
Inc.
Dysport® is a registered trademark of Ipsen Biopharm,
Ltd.
Xeomin® is a registered trademark of Merz Pharma Gmbh &
Co.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations 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.
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 of existing trends
and information as of the date of this release. Except as expressly
required by law,Allergan disclaims any intent or obligation to
update these forward-looking statements. 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 risks associated with
acquisition transactions; 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;
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 Quarterly Report on Form
10-Q for the quarter ended March 31, 2015 (such periodic
public filings having been filed under the "Actavis plc" name) and
from time to time in Allergan's other investor
communications . Except as expressly required by
law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
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SOURCE Allergan plc