FDA Approves Ipsen’s Dysport to Treat Upper Limb Spasticity in Children

The United States Food and Drug Administration has expanded the use of Dysport for injection to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy.

Spasticity affects more than an estimated 12 million people worldwide and is a condition in which there is an abnormal increase in muscle tone or stiffness, which may interfere with movement and particularly impacts growing children. Treatment with injectable medications, including Dysport, has shown to be effective in relieving the symptoms associated with spasticity in the arms and legs among children.

Pediatric spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness in one or more muscles, which might interfere with movement. Spasticity is usually caused by damage to nerve pathways in the brain or spinal cord that control muscle movement, and may occur in association with cerebral palsy, spinal cord injury, multiple sclerosis, stroke, and brain or head trauma. Symptoms of spasticity may include increased muscle tone, rapid muscle contractions, exaggerated deep tendon reflexes, and/or muscle spasms. The degree of spasticity can vary from mild muscle stiffness to severe, painful, and uncontrollable muscle spasms.

The approval was based on a pivotal phase 3 study demonstrating that Dysport improved spasticity symptoms in children aged two to 17 who experienced upper limb spasticity, as measured by the primary efficacy endpoint of Modified Ashworth Scale at elbow or wrist flexors at week 61.

This approval makes Dysport the first botulinum toxin approved by the FDA for both pediatric spasticity indications, following the previous approval to treat children with lower limb spasticity aged two and older received in July 2016.

“For physicians, it is reassuring to have a botulinum toxin treatment in Dysport which demonstrated sustained symptom relief for spasticity, which can be physically challenging for children,” said Ann Tilton, study investigator and professor of Clinical Neurology at the Louisiana State University Health Sciences Center New Orleans. “This FDA decision for Dysport means we now have an approved therapy to offer children and adolescents seeking improvements in mobility in both upper and lower limbs.”

Photo: Ann Tilton, study investigator and professor of Clinical Neurology at the Louisiana State University Health Sciences Center New Orleans

Author: Rare Daily Staff