FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy

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 11^th 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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