FDA Approves Expanded Indication for AbobotulinumtoxinA—Upper Limb Spasticity in Children Age 2 or More

The Food and Drug Administration (FDA) has approved expanded indications for abobotulinumtoxinA (Dysport; Ipsen Group, Cambridge, MA) to include treatment of upper limb spasticity in children age 2 years or more, excluding spasticity caused by cerebral palsy (CP). With this approval, abobotulinumtoxinA is the first botulinum toxin approved for 2 pediatric spasticity indications, having previously been approved for treatment of lower limb spasticity in those age 2 or more.

Approval is based on a phase 3 study (NCT02106351) in which 208 children, age 2 to 17 years, with upper limb spasticity, were treated with 2 U/kg, 8 U/kg, or 16 U/kg of abobotulinumtoxinA. At 6 weeks postinjection, children treated with 8U/kg or 16 U/kg had significantly less spasticity at the wrist and elbow flexors compared with those treated with 2 U/kg. Spasticity was measured by the Modified Ashworth Scale (MAS). Most children maintained these improvements through 12 weeks. 

AbobotulinumtoxinA demonstrated a reduction in spasticity symptoms through 12 weeks for most children, and most participants did not need retreatment until after 16 to 28 weeks. Some patients had a duration response as long as 34 weeks or more. 

“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, MD, professor of clinical neurology, Louisiana State University Health Sciences Center. “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.”

The primary targeted muscle groups (PTMG) were the elbow flexors, brachialis and brachioradialis, wrist flexors, flexor carpi radialis, and flexor carpi ulnaris. After the initial treatment, up to 3 further treatments of abobotulinumtoxinA could be administered at planned doses of either 8 units/kg or 16 units/kg or titrated up or down according to investigator judgement. AbobotulinumtoxinA has also been approved in the US for treatment of adults with cervical dystonia (CD) and spasticity.