Merz's confident submission to EMA

Introduction

Merz Therapeutics is a family renowned specialty pharmaceutical company smartly developing and introducing effective therapies for movement disorders, liver disease and neurological conditions. Since 2020, the company has been travelling across 90 countries with its expert-level performance in botulinum toxin. Merz’s XTRACT Technology™ works as a purifying processor for neurotoxins, alongside its products harnesses Parkinson’s, scar management and Alzheimer’s treatments.

Announcement

Merz Therapeutics submitted its application for XEOMIN® to the European Medicines Agency (EMA). This drug is to treat the spasticity of the lower and upper limbs in both adolescents and children, covering the 2-17 age group. If the European Union (EU) and the European Economic Area (EEA) approve this submission, then XEOMIN® can enter the well-developed botulinum neurotoxin therapy. Alongside, Europe will also get a new indication or formulation that might excel further in pediatric spasticity.

Submission based on the robust advancement

This confident submission is related to the advancement of the clinical dossier, following the Phase 3 ELLIE study data. Also, the main pediatric spasticity research was a huge support, assessing different treatments of the lower limb and accurate upper limb treatment. The overall results of the ELLIE study was ramped at TOXINS 2026, 8th International Congress on Neurotoxins organized from 14th to 17th January 2026.

The tolerability and safety rate were quite convincing to be considered further in any new indications. With this green signal, the submission doubled its power and has raised the expectation of approval.

Chief Scientific and Medical Officer, Merz Therapeutics, Dr Stefan Albrecht, said, “We are well aware of our regulatory decision for modernising our pediatric spasticity program. This submission is another success in our long-standing commitment to enhancing standards of care for the stressed spasticity patient group.”

Why is the approval for XEOMIN® important?

Spasticity is a general and disturbing condition visible in adolescents and children suffering from neurological conditions. This dilutes the muscle bone that can adversely affect the functioning and movement of the body, increasing the dependency rate. The spasticity is linked with CP, which can be deadly. To overcome this condition and fight the extremity, XEOMIN® is a shield, protecting the patients.

With this approval, Merz will be glad to fulfil its long-term commitment and provide a new solution to the vast healthcare market. Sometimes, it needs immense effort to meet the intensified and responsible goal of promoting patient care with precision.