Merz Therapeutics Seeks European Approval for XEOMIN in Pediatric Spasticity Treatment
核心洞察
Merz Therapeutics (搜索) has submitted a regulatory application to the European Medicines Agency (搜索) for XEOMIN (incobotulinumtoxinA) to treat spasticity (搜索) in children and adolescents aged 2-17 years.
The submission is supported by positive results from the Phase 3 ELLIE trial, which demonstrated significant improvement in lower limb spasticity (搜索) in children with cerebral palsy (搜索).
Spasticity (搜索) affects approximately 80% of children with cerebral palsy (搜索), the most frequent motor disability in childhood, significantly limiting movement and independence.
Merz Therapeutics (搜索) announced on January 26, 2026, that it has completed a regulatory submission to the European Medicines Agency (搜索) for XEOMIN (incobotulinumtoxinA) to treat spasticity (搜索) of the lower and upper limb in children and adolescents aged 2-17 years across the European Union and European Economic Area. The application represents a significant step toward expanding treatment options for pediatric patients with this debilitating neurological condition.
Clinical Need and Disease Impact
Spasticity (搜索) is a common and often debilitating condition in children and adolescents with certain neurological conditions, leading to increased muscle tone that can significantly limit movement, function and independence. Cerebral palsy (搜索) stands as the most common underlying cause of spasticity in children, representing the most frequent motor disability in childhood. Spastic forms account for approximately 80% of all cerebral palsy cases, highlighting the substantial patient population that could benefit from expanded treatment options.
In more severe cases, spasticity (搜索) associated with cerebral palsy (搜索) extends beyond mobility issues, affecting speech, swallowing and fine motor skills, further compromising patients' quality of life and independence.
Supporting Clinical Evidence
The regulatory package includes a comprehensive update of the clinical dossier, featuring data from the Phase 3 ELLIE study and prior pediatric spasticity (搜索) investigations evaluating multipattern treatment of the lower limb, and where appropriate, concomitant upper-limb treatment.
The Phase 3 ELLIE trial was a prospective, randomized, placebo-controlled, two-stage, double-blind, multicenter, 28-week clinical study that investigated incobotulinumtoxinA in treating lower limb spasticity (搜索) in children and adolescents with cerebral palsy (搜索). Results from this pivotal trial were recently presented at the TOXINS 2026 8th International Congress on Neurotoxins from January 14 to 17, 2026.
The study demonstrated that incobotulinumtoxinA significantly improved lower limb spasticity (搜索) in children and adolescents with cerebral palsy (搜索) while maintaining a favorable safety and tolerability profile. These positive outcomes form the foundation for the regulatory submission seeking to expand XEOMIN's approved indications.
Strategic Commitment to Pediatric Care
"We have made the conscious and ethical decision to advance our pediatric spasticity (搜索) program. The submission of this important application for an indication extension in Europe represents another 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).
The submission reflects Merz Therapeutics (搜索)' broader mission to address unmet needs in movement disorders, neurodegenerative conditions, and other health conditions that severely impact patients' quality of life. The company, headquartered in Frankfurt am Main, Germany, operates in more than 80 countries and is part of the Merz Group, a privately held, family-owned company with a 118-year legacy in healthcare innovation.
If approved, this indication would provide European healthcare providers with an established botulinum neurotoxin therapy specifically validated for some of the youngest and most vulnerable patients, potentially improving treatment outcomes and quality of life for children and adolescents living with spasticity (搜索) across the region.