Allergan, PLC issued the following announcement on March 7.
Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license applications (sBLAs) to expand the BOTOX® (onabotulinumtoxinA) label for the treatment of pediatric patients (2 years of age and older) with upper and lower limb spasticity. The pediatric upper limb spasticity indication has been designated a 6-month Priority Review with a Prescription Drug User Fee Act (PDUFA) date expected in the second quarter of this year. The pediatric lower limb spasticity indication will undergo a standard 10-month review with a PDUFA date expected in the fourth quarter of 2019. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs. The most common cause of focal spasticity in children is cerebral palsy, which occurs in an estimated 2.5 per 1,000 live births globally. Nearly all patients with cerebral palsy have impaired motor function, with spasticity affecting as many as 91 percent.
BOTOX® is the first FDA-approved neurotoxin treatment for both upper and lower limb spasticity in adults, 18 years and older. If approved, BOTOX® would be the first neurotoxin treatment indicated for use in both upper and lower limb pediatric spasticity.
"The FDA's acceptance of Allergan's supplemental biologics license applications is a monumental milestone on our journey to bring new treatment options to pediatric patients with upper and lower limb spasticity," said David Nicholson, Chief Research and Development Officer, Allergan. "BOTOX® has been used in a variety of therapeutic areas for the past 30 years since FDA approval of blepharospasm and strabismus, and we remain steadfast in our commitment to investing in research that explores the potential benefits of BOTOX® in treating patients across an array of therapeutic areas."
The sBLA submissions are based on data from four Phase 3 studies evaluating the safety and efficacy of BOTOX® in more than 600 pediatric patients with upper and lower limb spasticity.
"Pediatric spasticity is a significant concern and can negatively impact a child's development and quality of life, interfering with everyday activities such as walking, dressing and playing," said Heakyung Kim, M.D., Pediatric Rehabilitation Medicine at Columbia University Medical Center/New York Presbyterian Hospital. "Spasticity management in pediatrics is critical while children are growing and adaptable. Considering the negative effects of long-term spasticity, it is important to provide continuum of care throughout childhood into adulthood. The positive results for BOTOX® for the treatment of pediatric upper and lower limb spasticity are promising as we look to address unmet and ongoing needs in children and adolescents."
INDICATIONS
BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used:
It is not known whether BOTOX® is safe or effective for other types of muscle spasms.
BOTOX® (onabotulinumtoxinA) 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®:
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 its ingredients (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®.
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. 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 people receiving BOTOX® for upper limb spasticity. Upper respiratory infections were also reported more frequently in people with prior breathing related problems with spasticity.
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 medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you 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 injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, dry eyes; and drooping eyebrows.
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.
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