Germany-based Merz Therapeutics has received EU/EEA approval for Xeomin (incobotulinumtoxinA) to treat spasticity associated with pes equinus in children and adolescents with cerebral palsy (CP) aged 2 to 17 years, covering both ambulant and non-ambulant patients. The approval expands Xeomin’s European label into pediatric lower-limb spasticity, including both ambulant and non-ambulant patients aged 2 to 17 years with cerebral palsy, broadening the available botulinum toxin options in this setting.
Pes equinus, caused by tight calf muscles that force the foot into a downward-pointing position, is among the most functionally disruptive manifestations of spastic CP. Spastic variants account for roughly 80% of all CP diagnoses, according to Merz. The approval covers intramuscular injection of incobotulinumtoxinA into affected lower limb muscles, consistent with the drug's established route of administration in adult spasticity indications. Merz said the label extension follows a formal application submitted to the European Medicines Agency in January 2026.
The regulatory decision rests on the Phase III ELLIE (Evaluation of Lower Limb IncobotulinumtoxinA Efficacy) study, a prospective, randomized, placebo-controlled trial in children and adolescents with CP-associated lower limb spasticity. The study reported statistically significant improvement in pes equinus spasticity alongside a favorable safety and tolerability profile, the company said. A supporting Phase III study by Heinen et al. published in the Journal of Pediatric Rehabilitation Medicine in 2021 provided additional evidence for the program.