July 9, 2020: “Allergan, an AbbVie company announced that the U.S.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.
BOTOX®
BOTOX® is one of the most widely researched medications in the world, with a proven history as a therapeutic agent.
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.
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
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, 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.
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®:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life.
You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months - Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing
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.”
