The Food and Drug Administration (FDA) has approved the expanded use of Botox® (onabotulinumtoxinA; Allergan) for the treatment of spasticity in pediatric patients aged ≥2 years, including those with lower limb spasticity caused by cerebral palsy.
In October 2019, the Agency approved Botox for the treatment of pediatric lower limb spasticity based on data from a phase 3 study of 381 pediatric patients, however the approval excluded spasticity caused by cerebral palsy. The label extension was a result of Allergan and Ipsen, the manufacturer of Dysport® (abobotulinumtoxinA), selectively waiving their respective orphan exclusivity marketing rights in pediatric patients with cerebral palsy.
As such, the FDA also approved the expanded use of Dysport® (abobotulinumtoxinA) for the treatment of spasticity in pediatric patients aged ≥2 years, including those with upper limb spasticity caused by cerebral palsy; the drug had originally received FDA approval in September 2019 for upper limb spasticity that excluded spasticity caused by cerebral palsy based on data from a phase 3 study of 210 pediatric patients.
“The proactive step to resolve the uncertainty created by the previous [cerebral palsy] carveout enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper and lower limb spasticity,” said Sarah Helen (Sally) Evans, MD, Division Chief of Rehabilitation Medicine in the Department of Pediatrics at the Children’s Hospital of Philadelphia. “This update ensures patient care, and treating the child as a whole person, can be the focus for physicians and their caregivers when making treatment decisions for both upper and lower limb spasticity.”
Both products are also indicated to treat adult patients with upper and lower limb spasticity.