The U.S. Food and Drug Administration (FDA) approved Ipsen Biopharmaceuticals’ supplemental Biologics License Application for Dysport (abobotulinumtoxinA) injection for the treatment of lower limb spasticity in pediatric patients ages 2 and older.
Patients with spasticity have an abnormal increase in muscle tone or stiffness, which may interfere with movement or cause discomfort. The most common causes for spasticity are neurological diseases such as cerebral palsy, multiple sclerosis, traumatic brain injury and spinal cord injury.
“This approval means that, for the first time, physicians have an FDA-approved botulinum toxin with recommended dosing guidance for the treatment of children 2 years of age and older with lower limb spasticity based on a large registrational study,” said Ann Tilton, MD, professor of clinical neurology, chief, Section of Child Neurology at Louisiana State University School of Medicine, in a press release.
Dysport is based on botulinum toxin Type A, a compound based on a bacterium that inhibits the transmission of nerve impulses to the muscle. Botulinum toxin injections cause contracted muscles to relax, enabling patients to return to many of their daily activities while relieving symptoms and improving their quality of life.
Botulinum toxin (BT) is a neurotoxin, which works by weakening spastic muscles through selectively blocking the release of acetylcholine at the neuromuscular junction. Dysport is the first FDA-approved botulinum toxin for the treatment of lower limb spasticity in pediatric patients.
The BLA approval was based on the results of a randomized, multicenter, double-blind, placebo-controlled, global Phase 3 pivotal clinical trial conducted in 235 pediatric patients, ages 2 to 17, with lower limb spasticity caused by cerebral palsy resulting in dynamic equinus foot deformity. A total of 158 patients were treated with Dysport and 77 were treated with a placebo drug.
At weeks 4 and 12, patients receiving Dysport had significant improvements in the mean change from baseline in Modified Ashworth Scale in ankle plantar flexor muscle tone and in the mean Physician’s Global Assessment response to treatment score.
“Pediatric lower limb spasticity is a neurological condition that is commonly seen in children with cerebral palsy, which affects the communication between the brain and the muscles, resulting in movement and posture problems,” said Ipsen CEO Cynthia Schwalm.
“Dysport is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Ipsen is committed to providing patients, their caregivers and their physicians with a comprehensive support offering, including Dysport, the IPSEN CARES patient assistance program, and the C.L.I.M.B. injector training platform for healthcare providers.”
Gloria Johnson-Cusack, board chair of United Cerebral Palsy, said the organization is “honored to work with responsible companies like Ipsen” to help meet the needs of people with cerebral palsy and other conditions.
“Lower limb spasticity in pediatric patients with cerebral palsy represents a significant unmet treatment need, as there have been no FDA-approved botulinum toxin treatment options available until now. It is our hope that the work of Ipsen in this area will benefit many individual pediatric patients who struggle with lower limb spasticity,” she said.
Dysport and all botulinum toxin products have a boxed warning stating that it may cause serious side effects that can be life threatening, including problems in breathing or swallowing, and spread of toxin effects. These problems can happen within hours, or days to weeks after an injection of Dysport.
The drug should not be used in patients with hypersensitivity to botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection sites; or in patients allergic to protein from cow’s milk.
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