FDA Accepts Supplemental Biologics License Application (sBLA) for BOTOX® (onabotulinumtoxinA) for the Treatment of Pediatric Patients with Neurogenic Detrusor Overactivity
NORTH CHICAGO, Ill., June 22, 2020 /PRNewswire/ -- Allergan, Inc., an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA) to expand the BOTOX® prescribing information for the treatment of signs and symptoms of detrusor (bladder muscle) overactivity associated with an underlying neurologic condition (e.g., spina bifida, spinal cord injuries) in pediatric patients (5 -17 years of age) who have an inadequate response to, or are intolerant of, or for any reason unwilling to continue anticholinergic medication.
The sBLA is based on data from a randomized, double-blind Phase 3 study evaluating the safety and efficacy of BOTOX® in more than 100 pediatric patients with neurogenic detrusor overactivity and a long-term extension study. The Prescription Drug User Fee Act date is expected to be in the first quarter of 2021 following a standard 10-month review.
"The FDA acceptance of this application underscores our ongoing commitment to pursuing the full potential of BOTOX® to serve patients across a wide spectrum of diseases and clinical needs," said Mitchell F. Brin, M.D., Senior Vice President, Chief Scientific Officer, BOTOX® & Neurotoxins, AbbVie. "Children living with neurogenic detrusor overactivity currently have limited options when they fail anticholinergic medications and prior to surgical intervention. If approved, BOTOX® will be the first neurotoxin treatment approved for use in treating detrusor overactivity in pediatric patients with an underlying neurologic condition who are not adequately managed by anticholinergic medications."
Neurogenic detrusor overactivity results from the inability of the spinal cord and bladder to communicate effectively. As a result, the bladder muscle (detrusor) involuntarily contracts, increasing the pressure in the bladder and reducing the bladder capacity, which can cause the individual to leak urine frequently and unexpectedly. If not adequately managed with clean intermittent catheterization and anticholinergic drugs, this condition may require augmentation cystoplasty (an extensive surgical procedure in which the bladder is enlarged using a section of the patient's intestine) to prevent renal damage.
There are a number of causes of neurogenic detrusor overactivity in children, such as transverse myelitis, spinal cord injury, and spina bifida, which is the most common and affects 1,500-2,000 of the more than 4 million babies born in the United States each year.1 More than 90% of those living with spina bifida experience urinary symptoms.2,3,4,5
"Over time, many pediatric patients with underlying neurologic conditions experience bladder and kidney damage, and treatment is critical," said Paul F. Austin, M.D., FAAP, Chief of Pediatric Urology at Texas Children's Hospital and Professor of Urology at Baylor College of Medicine. "Current treatment options often include anticholinergic medications, where long-term use needs to be considered carefully, in addition to surgery. The favorable BOTOX® clinical results for the treatment of pediatric patients with neurogenic detrusor activity are promising as we look to address unmet and ongoing needs in children and adolescents."
BOTOX® is the first and only neurotoxin approved for the treatment of leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition in adults who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication. BOTOX® temporarily reduces muscle contractions by blocking the transmission of nerve impulses to the muscle, in this case, the bladder muscle, by selectively preventing the release of the neurotransmitter acetylcholine at the neuromuscular junction.
BOTOX® (onabotulinumtoxinA) Important Information
BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
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 in lower limb muscles other than those in the ankle and toes in people 18 years and older. 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.
It is not known whether BOTOX® is safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.
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®:
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 Chronic Migraine, severe underarm sweating, 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.
Do not receive BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post treatment, if required, should be considered for treatment.
Patients treated for overactive bladder:
Patients treated for overactive bladder due to neurologic disease:
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 or for detrusor overactivity associated with a neurologic condition. 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 adults receiving BOTOX® for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing related problems with spasticity. 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 infections were not reported more frequently than placebo.
Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
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; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; 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. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
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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