Health Canada has approved Dysport (abobotulinumtoxinA) for the treatment of leg spasticity in children and teens ages 2 and older, including those with cerebral palsy.
The treatment, which reduces spasticity by blocking nerve signaling, was previously shown to effectively improve muscle tone and movement ability in children. It also improved measures of general health.
“With the Health Canada approval of Dysport Therapeutic, children with cerebral palsy and their parents can look forward to another therapy which improves stiffness and movement that are hallmarks of cerebral palsy,” Janice Bushfield, executive director of the Cerebral Palsy Association in Alberta, said in a press release.
“It is wonderful news for this community since, when it comes to medication and cerebral palsy, one size does not fit all,” Bushfield added.
Dysport, developed by Ipsen, was approved in the U.S. in 2016 for leg spasticity in this pediatric patient group.
An earlier Phase 3 trial (NCT01249417) and its extension (NCT01251380) demonstrated that Dysport improved walking and balance, decreased falling and tripping, and improved endurance in children and teens ages 2 to 17.
The studies included patients who could walk, but had so-called equinus foot deformity caused by cerebral palsy. Patients also received other treatments during the clinical trials. The Phase 3 extension study showed that repeated injections of the medication were safe.
“The stiffness that accompanies pediatric lower limb spasticity can be painful and disabling for children who suffer from movement disorders, including cerebral palsy,” said Michael Shevell, chair of the Department of Pediatrics at McGill University in Canada.
“Additional choices for this patient population are required since current regimens may not be suitable for every child and treatment needs to be individualized,” he said.
The majority of patients with cerebral palsy have leg spasticity, which makes walking more difficult in 80 percent of children with the condition. Spasticity is often caused by damage to the spinal cord or parts of the brain that control movement, making some neurons overactive.
Dysport prevents spasticity by blocking signals from these neurons.
“The approval of Dysport Therapeutic in this pediatric indication demonstrates Ipsen Canada’s ongoing commitment to spasticity and neuromuscular disorders,” said Paul Reider, general manager for Ipsen Canada.
“We are proud to play a role in improving the lives of families who are affected by pediatric lower limb spasticity by continuing to expand the indications for this important treatment option,” Reider added.