FDA Approves Expanded Botox (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity


NORTH CHICAGO, Ill., July 9, 2020 /PRNewswire/ — Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) that supports expanded use of Botox® for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.

This label expansion is based on Allergan and another manufacturer selectively waiving orphan exclusivity marketing rights each company held for the use of their respective neurotoxins in the treatment of pediatric patients with spasticity caused by cerebral palsy. Botox® was first approved in June 2019 for the treatment of pediatric patients with upper limb spasticity and in October 2019 for the treatment of pediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy. Botox® has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture.

Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs. The severity can range from mild to severe, often interfering with normal muscular movement and function. This can result in delayed or impaired motor development, as well as difficulty with posture and positioning. Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke.

“Cerebral palsy is the most common cause of pediatric spasticity, which can have a profound impact on a child’s development and quality of life. With its established safety and efficacy profile, we are pleased that Botox® can now more broadly support physicians treating pediatric spasticity,” said Mitchell F. Brin, M.D., Senior Vice President, Chief Scientific Officer, Botox® & Neurotoxins, AbbVie. “Building upon our 30 years of research and development efforts with Botox®, our commitment to neurotoxin innovation continues, and it is particularly rewarding to bring forth new treatments to advance care for pediatric patients.”

The safety and efficacy of Botox® as treatment for lower limb spasticity for pediatric patients is supported by a Phase 3 study with more than 300 patients two to 17 years of age with lower limb spasticity because of cerebral palsy. These trials included a 12-week, double-blind study and a one-year open-label extension study.

Allergan is committed to providing resources and services, such as the BOTOX® Savings Program, to help ensure BOTOX® is accessible and affordable to patients.

About Botox

Botox® is one of the most widely researched medications in the world, with a proven history as a therapeutic agent.1 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 11 therapeutic indications, including Chronic Migraine, overactive bladder, leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition, cervical dystonia, spasticity, and severe underarm sweating (axillary hyperhidrosis). Backed by strong science and continuous innovation, BOTOX® proudly embraces its past while boldly looking to the future.

Botox (onabotulinumtoxinA) Important Information

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, a strong need to urinate right away, and urinating often 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 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 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 or 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 or effective for severe sweating anywhere other than your armpits. 

About AbbVie

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.

Forward-Looking Statements

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, competition from other products, challenges to intellectual property, 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. 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. Data on file, Allergan; BOTOX® Worldwide Marketing Authorization Status; BOTOX® Prescribing Information


Posted: July 2020

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