FRANKFURT AM MAIN, Germany — September 17, 2026

Merz Therapeutics announced that it has received European Union and European Economic Area approval for XEOMIN® (incobotulinumtoxinA) for the symptomatic treatment of spasticity associated with pes equinus in children and adolescents with cerebral palsy aged 2 to 17 years. The approval covers both ambulant and non-ambulant patients, expanding the eligible pediatric population for XEOMIN treatment across Europe. Pes equinus occurs when tight calf muscles cause the foot to point downward and can interfere with mobility and physical function. The regulatory decision represents Merz Therapeutics’ first European approval for the symptomatic treatment of pediatric lower-limb spasticity and expands the company’s specialty neurology portfolio into an important pediatric population.

Phase 3 ELLIE Study Supports XEOMIN Approval

The EU/EEA regulatory decision is supported by clinical evidence including positive results from the Phase 3 ELLIE study, a prospective, randomized and placebo-controlled clinical trial evaluating XEOMIN in children and adolescents with cerebral palsy. The study demonstrated that XEOMIN significantly improved spasticity associated with pes equinus while maintaining a favorable safety and tolerability profile. The results provided the clinical foundation for submissions to national competent authorities across the EU/EEA. Merz Therapeutics said the approval expands access to an established botulinum neurotoxin therapy for pediatric patients whose lower-limb spasticity can affect movement, daily activities and independence. The broader indication includes children who can walk as well as those who are non-ambulant, reflecting the different functional needs of patients with cerebral palsy.

Pediatric Cerebral Palsy Creates Significant Treatment Need

Spasticity is a common and potentially disabling manifestation of cerebral palsy, which remains the most prevalent childhood motor disability. Spastic forms account for approximately 80% of cerebral palsy diagnoses, according to the company’s cited sources. Muscle tightness can restrict movement and daily functioning, while children with more severe cerebral palsy may also experience challenges involving speech, swallowing and fine motor activities. Pes equinus specifically affects the positioning and function of the foot and can contribute to mobility limitations. By expanding XEOMIN into symptomatic pediatric lower-limb spasticity, Merz Therapeutics is addressing a treatment area in which management often requires multidisciplinary care and individualized approaches. The approval therefore broadens the potential role of botulinum neurotoxin therapy within pediatric spasticity management across European healthcare systems.

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Merz Therapeutics Strengthens European Neurology Strategy

The XEOMIN approval strengthens Merz Therapeutics’ broader strategy in specialty neurology and pediatric patient access across Europe. The company operates in more than 80 countries and focuses on conditions including movement disorders, neurodegenerative diseases and other disorders that substantially affect quality of life. Merz Therapeutics said the new approval reflects continued investment in clinical development and regulatory activities designed to address unmet needs in neurology. The company will now work across European markets where national implementation, reimbursement and healthcare-system processes can influence patient access following EU/EEA approval. By extending XEOMIN to children and adolescents aged 2 to 17 years with cerebral palsy-associated pes equinus, including both ambulant and non-ambulant patients, Merz Therapeutics is expanding its pediatric neurology footprint while adding a new approved treatment option for lower-limb spasticity.

Source: Merz Therapeutics press release