Key takeaways:

• The label update expands incobotulinumtoxinA’s upper limb spasticity indication to include children and adolescents with cerebral palsy.
• The medication is indicated for use to treat increased muscle stiffness.

Merz Therapeutics announced the FDA approved a label update to expand incobotulinumtoxinA’s pediatric upper limb spasticity indication to include children and adolescents aged at least 2 years with cerebral palsy.

IncobotulinumtoxinA (Xeomin) was previously approved by the FDA in 2010 for adults with cervical dystonia after showing improvements in clinical studies for cervical dystonia-related severity, disability and pain, according to a company press release.

“Spasticity associated with cerebral palsy can place a significant burden on children and families, affecting comfort, independence and participation in everyday routines,” Len Paolillo, president of Merz Therapeutics, North America, said in the release. “This label update expands the opportunity to treat pediatric upper limb spasticity in patients with cerebral palsy.”

According to the release, incobotulinumtoxinA is indicated for use to “treat increased muscle stiffness in the arm because of upper limb spasticity in adults and children 2 years of age and older.”

The most common adverse events of incobotulinumtoxinA in children and adolescents aged 2 to 17 years with upper limb spasticity include nasal congestion, sore throat and runny nose and bronchitis, according to the release.