Merz Therapeutics Receives EU/EEA Approval for XEOMIN® for the Treatment of Pediatric Spasticity Associated With Pes Equinus

Approval expands XEOMIN use to include the symptomatic treatment of spasticity associated with pes equinus in children and adolescents with cerebral palsy aged 2 to 17 years. Approval includes both children and adolescents who are able to walk and those who are non-ambulant, broadening the population eligible for XEOMIN treatment

FRANKFURT AM MAIN, Germany--(BUSINESS WIRE)--Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has received approval in the European Union (EU) / European Economic Area (EEA) for XEOMIN® (incobotulinumtoxinA) for the symptomatic treatment of spasticity associated with pes equinus, a condition in which tight calf muscles cause the foot to point downward, in ambulant and non-ambulant children and adolescents with cerebral palsy (CP) aged 2 to 17 years.^1,2 This approval expands access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe.

Spasticity is a common and often disruptive symptom in children and adolescents with neurological conditions, including CP. This condition is associated with muscle tightness that can severely restrict physical movement, daily functioning, and personal autonomy. Among children and youth, CP stands as a primary driver of this symptom and remains the most prevalent childhood motor disability, with spastic variants representing roughly 80% of all diagnoses. In more severe presentations, children with CP may additionally experience difficulties with speaking, swallowing and fine motor tasks.^3,4

“We are proud to announce this first approval for the symptomatic treatment in pediatric lower limb spasticity 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, Merz Therapeutics. “This achievement reflects our continued investment in advancing innovative approaches to neurology and addressing significant unmet patient needs.”

The regulatory decision is based on a comprehensive clinical program, including the positive results of the Phase 3 ELLIE study, submitted to the National Competent Authorities in the EU/EEA. The prospective, randomized, placebo-controlled study demonstrated that XEOMIN significantly improved spasticity associated with pes equinus in children and adolescents with CP, while showing a favorable safety and tolerability profile.^1,2

“The approval of XEOMIN for the treatment of pediatric spasticity represents exactly what we're building here at Merz Therapeutics – the ability to move quickly across European healthcare systems to pave the way for life-changing therapies to reach the patients who need them most," said Dan Staner, President Region Europe, Merz Therapeutics. "Across diverse regulatory landscapes and reimbursement frameworks, we've worked tirelessly to clear the path for children and adolescents to benefit from this treatment. For us, this is proof of how collaborative leadership and a relentless focus on patient access can transform specialty neurology in Europe.

About Merz Therapeutics

Merz Therapeutics GmbH is dedicated to delivering better outcomes for more patients. With science as its foundation and patient experience as its focus, the company relentlessly pursues innovative treatments and partnerships to address unmet needs in movement disorders, neurodegenerative conditions, liver disease, and other health conditions that severely impact patients’ quality of life.

Merz Therapeutics is headquartered in Frankfurt am Main, Germany, and is active in more than 80 countries. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company with an 118-year legacy. With passion and purpose, Merz Therapeutics continues to advance care in specialty neurology in ways that benefit both patients and society.

Please visit www.merztherapeutics.com.

References

1. Banach M, Makedonska I, Mykhaylenko V, et al. IncobotulinumtoxinA for the treatment of lower limb spasticity in children and adolescents with cerebral palsy: Evaluation of Lower Limb IncobotulinumtoxinA Efficacy (ELLIE). Toxicon. 2026;271 (Suppl. 1): 108685. https://doi.org/10.1016/j.toxicon.2025.108685.
2. Heinen F, Kanovský P, Schroeder AS, et al. IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study. J Pediatr Rehabil Med. 2021;14(2):183-197. doi:10.3233/PRM-210040
3. Cerebral Palsy Guide. Spastic cerebral palsy. Accessed June 17, 2026. https://www.cerebralpalsyguide.com/cerebral-palsy/types/spastic/
4. Centers for Disease Control and Prevention. Data and Statistics for Cerebral Palsy. Accessed June 17, 2026. https://archive.cdc.gov/www_cdc_gov/ncbddd/cp/data.html