Merz Therapeutics Wins EU/EEA Approval for Xeomin in Pediatric Pes Equinus Spasticity
核心洞察
Merz Therapeutics (搜索) has received EU/EEA approval for Xeomin (incobotulinumtoxinA) to treat spasticity (搜索) associated with pes equinus (搜索) in children and adolescents with cerebral palsy (搜索).
The label expansion covers patients aged 2 to 17 years and includes both ambulant and non-ambulant children, broadening the population eligible for the botulinum neurotoxin therapy.
The regulatory decision rests on the Phase 3 ELLIE study, a prospective, randomized, placebo-controlled trial that showed significant spasticity (搜索) improvement with a favorable safety profile.
Merz Therapeutics (搜索) has received approval in the European Union and European Economic Area for XEOMIN (incobotulinumtoxinA) for the symptomatic treatment of spasticity (搜索) associated with pes equinus (搜索) in children and adolescents with cerebral palsy (搜索) aged 2 to 17 years. The Frankfurt am Main-based specialty pharma company announced the decision on September 17, 2026.
The approval covers both ambulant and non-ambulant patients, broadening the population eligible for treatment with the botulinum neurotoxin type A therapy. Pes equinus (搜索) is caused by tight calf muscles that force the foot into a downward-pointing position and is among the most functionally disruptive manifestations of spastic cerebral palsy (搜索).
"This approval expands access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe," Merz said in announcing the decision.
Disease Burden and Unmet Need
Spasticity (搜索) is a common and often disruptive symptom in children and adolescents with neurological conditions, including cerebral palsy (搜索). The condition involves muscle tightness that can severely restrict physical movement, daily functioning and personal autonomy.
Cerebral palsy (搜索) is a primary driver of spasticity (搜索) in children and youth and remains the most prevalent childhood motor disability. Spastic variants account for roughly 80% of all cerebral palsy diagnoses, according to Merz. In more severe presentations, children with cerebral palsy may also experience difficulties with speaking, swallowing and fine motor tasks.
"We are proud to announce this first approval for the symptomatic treatment in pediatric lower limb spasticity (搜索) in Europe, marking another significant milestone in our long-term commitment to improving standards of care for children and adolescents living with spasticity," said Dr. Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics (搜索). "This achievement reflects our continued investment in advancing innovative approaches to neurology and addressing significant unmet patient needs."
Phase 3 ELLIE Trial Supports Approval
The regulatory decision is based on a comprehensive clinical program that included the Phase 3 ELLIE (Evaluation of Lower Limb IncobotulinumtoxinA Efficacy) study, submitted to the National Competent Authorities in the EU/EEA. ELLIE was a prospective, randomized, placebo-controlled trial in children and adolescents with cerebral palsy (搜索)-associated lower limb spasticity (搜索).
The study demonstrated that XEOMIN significantly improved spasticity (搜索) associated with pes equinus (搜索) in this population while showing a favorable safety and tolerability profile, according to the company. A supporting Phase 3 study by Heinen et al., published in the Journal of Pediatric Rehabilitation Medicine in 2021, provided additional evidence for the program.
Merz said the label extension follows a formal application submitted to the European Medicines Agency in January 2026.
Mechanism and Administration
IncobotulinumtoxinA is a botulinum neurotoxin type A formulation free of complexing proteins, which Merz has attributed to a potentially reduced immunogenic load compared with complex-containing formulations. Head-to-head comparative data are not cited in the source material. The agent acts by blocking acetylcholine release at the neuromuscular junction, producing temporary, localized muscle relaxation.
The approval covers intramuscular injection of incobotulinumtoxinA into affected lower limb muscles, consistent with the drug's established route of administration in adult spasticity (搜索) indications.