FDA Approves Expanded Botox (onabotulinumtoxinA) Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity

NORTH CHICAGO, Ill., July 29, 2021 /PRNewswire/ — Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of Botox® to include eight new muscles for the treatment of upper limb spasticity in adults. The new muscles for treatment include additional muscles of the elbow and forearm (brachialis, brachioradialis, pronator teres, and pronator quadratus), as well as intrinsic hand muscles (lumbricals and interossei) and thumb muscles (flexor pollicis brevis and opponens pollicis). The label now includes the use of ultrasound as a muscle localization technique in adult spasticity.

“Today’s announcement is especially important because spasticity is a disabling neurological condition that can have a significant impact on a patient’s quality of life,” said Mitchell F. Brin, M.D., Senior Vice President, Chief Scientific Officer, Botox® & Neurotoxins, AbbVie. “This label expansion not only adds to our rich history in neurotoxin science, but also reinforces the role of Botox® in upper limb spasticity treatment. Botox® provides an evidence-based dosing strategy to meet the clinical needs of providers and their patients.”

Spasticity in adults is commonly caused by stroke, multiple sclerosis, spinal cord injury, cerebral palsy, and traumatic brain injury. Individuals with spasticity experience stiffness in the muscles of their upper and/or lower limbs, and may have difficulty with voluntary control. Upper limb spasticity can manifest as a bent elbow, an arm pressed against the chest, or a curled-in hand with a clenched fist, significantly hindering the patient’s ability to perform everyday activities. This can result in difficulty with posture and positioning, and severely interfere with normal muscular movement and function.

Botox® has been proven to significantly reduce muscle stiffness and is indicated for the treatment of spasticity in patients 2 years of age and older. This expanded Botox® dosing guidance provides physicians the ability to treat based on clinical assessment of a patient’s spasticity and anatomy while staying within the Botox® maximum cumulative dose of 400 Units in a 3-month period in adults. Botox® has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture. The safety profile of Botox® in adult upper limb spasticity remains the same, with the most common adverse reactions including nausea, fatigue, bronchitis, pain in extremity and muscular weakness.

“Botox® has demonstrated efficacy and safety for spasticity management at clinically proven doses,” said Kimberly Heckert, M.D., Director, Spasticity Management Fellowship, Thomas Jefferson University of Philadelphia. “This label expansion offers physicians and their patients living with spasticity another important tool as part of a comprehensive treatment plan for spasticity management.”

Botox® Training and Support Programs

Allergan offers a variety of expert-based Botox® education and technical training programs to help physicians enhance their clinical skills and injection practices. These training programs focus on using guidance techniques, such as EMG, nerve stimulation, and now ultrasound, to help localize muscles for Botox® injection in adults with spasticity. In addition, the company 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® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. 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, adult and pediatric spasticity, severe underarm sweating (axillary hyperhidrosis), and pediatric detrusor overactivity associated with a neurologic condition.

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, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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.


Posted: July 2021

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  • 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
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  • FDA Approves Botox to Treat Chronic Migraine – October 15, 2010
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Botox (onabotulinumtoxinA) FDA Approval History

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