The Food and Drug Administration approved drug company Allergan’s supplemental biologics application for Botox for patients 2-17 years old with upper limb spasticity.
Spasticity can occur as a result of brain and spine damage from cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke.
“Watching a child suffering with any degree of upper limb spasticity is very difficult,” said David Nicholson, chief research and development officer at Allergan. “This FDA approval is special to all of us at Allergan because we can now provide children and their caregivers an advancement in pediatric care.”
The treatment session dose approved is 3 units per kilogram to 6 units per kilogram divided among the affected muscle groups.
“Pediatric upper limb spasticity is a significant concern and can negatively impact a child's development and quality of life," said Mark Gormley, pediatric rehabilitation medicine specialist at Gillette Children's Specialty Healthcare-St. Paul. “Because spasticity is particularly debilitating to growing children, it requires ongoing care.”