FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity
- Category: Proteins and Peptides
- Published on Friday, 30 July 2021 10:55
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-- 6.7 million adults in the U.S. are living with spasticity across a variety of neurologic conditions
-- BOTOX® has demonstrated efficacy and has an established safety profile with over 10 years of clinical use in adult upper limb spasticity
NORTH CHICAGO, IL, USA I July 29, 2021 I 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.
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.
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 (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.