Botox (onabotulinumtoxinA) Receives FDA Approval for Pediatric Detrusor Overactivity Associated with a Neurologic Condition
NORTH CHICAGO, Ill., Feb. 10, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved Botox® for the treatment of detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication.
Neurogenic detrusor overactivity occurs when the spinal cord and bladder are not able to communicate effectively, which can occur with neurologic conditions such as spina bifida and spinal cord injuries. As a result, the bladder muscle involuntarily contracts, increasing the pressure in the bladder and reducing the bladder capacity, which can cause the individual to leak urine frequently and unexpectedly. Elevated bladder pressure can also lead to bladder and kidney damage over time.
"Botox® is the first neurotoxin approved for use in treating neurogenic detrusor overactivity in children who are not adequately managed with anticholinergic medication. While always satisfying to bring forth new indications, it is particularly rewarding when we can help advance care for pediatric patients with Botox®," said Mitchell F. Brin, M.D., Senior Vice President, Chief Scientific Officer, Botox® & Neurotoxins, AbbVie. "This milestone marks the 12th approved therapeutic indication for Botox®, adding another approved use to the pediatric portfolio. Building upon our 30-year heritage in BOTOX® research and development, we remain steadfast in our pursuit of neurotoxin innovation to address unmet medical needs across therapeutic areas."
The FDA approval 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. Results from the Phase 3 study demonstrated that intradetrusor administration of Botox® 200 Units (not to exceed 6U/kg) reduced daytime urinary incontinence episodes, the study's primary endpoint, as well as lowered maximum bladder pressure and increased bladder capacity at week 6 (primary timepoint). The most common adverse reaction in the studies were bacteriuria (20%), urinary tract infection (7%), leukocyturia (7%), and hematuria (3%).
"Many children with underlying neurologic conditions may experience bladder and kidney damage over time, which underscores the importance of treatment. When caring for pediatric patients with neurogenic detrusor overactivity, we strive to reduce bladder pressure and increase the bladder's capacity. Previously, treatment options were limited primarily to anticholinergic medicines, where long-term use needs to be considered carefully, in addition to surgery," 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. "Effectively managing neurogenic detrusor overactivity requires ongoing care, and there has been a high unmet need for alternative treatments. With its proven safety and efficacy profile, Botox® offers a new treatment option for pediatric patients who are not adequately managed by anticholinergics."
There are several causes of neurogenic detrusor overactivity in children, such as transverse myelitis, spinal cord injury, and spina bifida, the latter of 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
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® is one of the most widely researched medications in the world, with a proven history as a therapeutic agent.6 First approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults, Botox® was the world's first approved botulinum toxin type A treatment. Today, Botox® is FDA-approved for 12 therapeutic indications, including Chronic Migraine, overactive bladder, leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition in adults, cervical dystonia, spasticity, severe underarm sweating (axillary hyperhidrosis), and pediatric detrusor overactivity associated with a neurologic condition. Backed by strong science and continuous innovation, Botox® proudly embraces its past while boldly looking to the future.
Botox® (onabotulinumtoxinA) Indications
Botox® is a prescription medicine that is injected into muscles and used:
- To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
- To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder caused by a neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
- To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
- To prevent headaches in adults with Chronic Migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
- To treat increased muscle stiffness in people 2 years of age and older with spasticity
- To treat the abnormal head position and neck pain that happens with Cervical Dystonia (CD) in people 16 years and older
- To treat certain types of eye muscle problems (Strabismus) or abnormal spasm of the eyelids (Blepharospasm) in people 12 years of age and older
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 and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
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 and effective for severe sweating anywhere other than your armpits.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the failure to realize the expected benefits of AbbVie's acquisition of Allergan or to promptly and effectively integrate Allergan's business, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
- 1.National Institute of Neurological Disorders and Stroke. Spina Bifida Fact Sheet. Accessed online 5/6/2020 and available from: https://www.ninds.nih.gov/disorders/patient-caregiver-education/fact- sheets/spina-bifida-fact-sheet.
2.Hascoet J, Manunta A, Brochard C, Arnaud A, Damphousse M, Menard H, et al. Outcomes of intra- detrusor injections of botulinum toxin in patients with spina bifida: A systematic review. Neurourology and Urodynamics. 2017;36(3):557-564.
3.Pannek J, Blok B, Castro-Diaz D, Del Popolo G, Kramer G, Radziszewski P, et. al. Guidelines on neurogenic lower urinary tract dysfunction. European Association of Urology, 2013. Available from: https://uroweb.org/wp-content/uploads/20_Neurogenic-LUTD_LR.pdf.
4.Shin M, Besser LM, Siffel C, Kucik JE, Shaw GM, Lu C, Correa A; Congenital Anomaly Multistate Prevalence and Survival Collaborative. Prevalence of spina bifida among children and adolescents in 10 regions in the United States. Pediatrics. 2010;126(2):274-279.
5.Ouyang L, Grosse SD, Armour BS, Waitzman NJ. Health care expenditures of children and adults with spina bifida in a privately insured U.S. population. Birth Defects Research Part A, Clinical and Molecular Teratology. 2007;79(7):552-558.
6.Data on file, Allergan; BOTOX® Worldwide Marketing Authorization Status; BOTOX® Prescribing Information.
Posted: February 2021
- FDA Approves Expanded Botox (onabotulinumtoxinA) Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity - July 29, 2021
- FDA Approves Expanded Botox (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity - July 9, 2020
- FDA Approves Botox (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy - October 24, 2019
- FDA Approves Botox (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity - June 21, 2019
- FDA Approves Botox (onabotulinumtoxinA) for the Treatment of Lower Limb Spasticity - January 22, 2016
- FDA Approves Botox to Treat Overactive Bladder - January 18, 2013
- FDA Approves Botox to Treat Specific Form of Urinary Incontinence - August 24, 2011
- FDA Approves Botox to Treat Chronic Migraine - October 15, 2010
- Botox (onabotulinumtoxinA) Receives FDA Approval for Treatment of Upper Limb Spasticity in Adults - March 10, 2010
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