Merz Therapeutics Submits Application to the European Medicines Agency for New Indication of XEOMIN® in Pediatric Spasticity

Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has completed the regulatory submission for XEOMIN^® (incobotulinumtoxinA) for the treatment of spasticity of the lower and upper limb in children and adolescents aged 2–17 years in the European Union (EU) and European Economic Area (EEA). If approved, the indication would expand access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe.

Spasticity 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. One of the most common underlying causes of spasticity in children is cerebral palsy (CP), the most frequent motor disability in childhood, with spastic forms accounting for approximately 80% of all cases. In more severe cases, spasticity associated with CP can also affect speech, swallowing and fine motor skills.^1,2

“We have made the conscious and ethical decision to advance our pediatric spasticity 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, Merz Therapeutics.

Submission based on comprehensive clinical dossier update

The regulatory package submitted to the European Medicines Agency includes a comprehensive update of the clinical dossier, with data from the Phase 3 ELLIE study and prior pediatric spasticity investigations evaluating multipattern treatment of the lower limb, and, where appropriate, concomitant upper‑limb treatment.

The positive results of the prospective, randomized, placebo-controlled, two-stage, double-blind, multicenter, 28-week Phase 3 clinical trial ELLIE were recently presented at the TOXINS 2026 8^th International Congress on Neurotoxins from January 14 to 17, 2026. The Phase 3 trial investigated incobotulinumtoxinA in the treatment of lower limb spasticity in children and adolescents with CP and showed how incobotulinumtoxinA significantly improved lower limb spasticity in children and adolescents with CP, while demonstrating a favorable safety and tolerability profile.³

About Merz Therapeutics

Merz Therapeutics GmbH is dedicated to delivering better outcomes for more patients. With science as its foundation and the 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 a 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 Cerebral Palsy Guide. Spastic cerebral palsy. https://www.cerebralpalsyguide.com/cerebral-palsy/types/spastic/. Last accessed: 19.01.2026.
² Centers For Disease Control and Prevention. Data and Statics for Cerebral Palsy. https://archive.cdc.gov/www_cdc_gov/ncbddd/cp/data.html. Last accessed: 19.01.2026.
³ Banach M et al. IncobotulinumtoxinA for treatment of lower limb spasticity in children/adolescents with CP (ELLIE). Toxicon. 2026;271(S1):7. Abstract 0076.

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