Neurotoxin

XEOMIN® (incobotulinumtoxinA) Receives European Approval for the Treatment of Chronic Sialorrhea in Children

Frankfurt, Germany,August 31, 2021

First and only botulinum neurotoxin approved for this indication in Europe

 Today, Merz Therapeutics, a business of the Merz Group and a leader in the field of neurotoxins, has been granted the use of XEOMIN^® for the symptomatic treatment in children and adolescents aged 2 to 17 years and weighing ≥ 12 kg of chronic sialorrhea due to neurological / neurodevelopmental disorders on EU level.¹ The national approvals of the country authorities involved will follow in the next weeks. The U.S. Food and Drug Administration granted approval in December 2020, and the Russian Federal Service for Surveillance in Healthcare in spring 2021.

Stefan Brinkmann, CEO Merz Therapeutics: “At Merz Therapeutics, we do everything to bring better outcomes to more patients. As XEOMIN^® is already approved for the treatment of adult sialorrhea, we can now offer life-long treatment with our botulinum toxin A, staying a trusted partner for sialorrhea patients as well as their relatives and physicians for a lifetime.”

Dr. Marcus Gollub, President, Head of Region Europe complements: “Pediatric sialorrhea is a serious condition that can significantly impact not only the medical condition but also the quality of life of the children and their families. I am happy that with this new indication we are able to take care of the needs of those children suffering from drooling and contribute to a better life for them and their families.”

Sialorrhea, also known as drooling, is a symptom that occurs when excessive saliva accumulates in the mouth. It is a chronic impairment often seen in children with neurological disorders (e.g. cerebral palsy or traumatic brain injury) and/or intellectual disability or neurodegenerative diseases.

The approval by European authorities for the use of XEOMIN^® for pediatric patients suffering from chronic sialorrhea, was achieved due to the convincing results of the SIPEXI study (Sialorrhea Pediatric Xeomin Investigation). It was a prospective, randomized, double-blind, placebo-controlled, multicenter phase III study with an extension phase evaluating the safety and efficacy of XEOMIN^® in 255 children and adolescents aged 2 – 17 years up to 64 weeks. The study recently got published in Neurology, the premier peer-reviewed journal for clinical neurology research.²

XEOMIN^® is being distributed by Merz Pharmaceuticals GmbH in more than 70 countries to treat patients with upper and lower limb spasticity, cervical dystonia, blepharospasm or hypersalivation. Merz uses state-of-the-art technology in its dedicated facility in Dessau, Germany, meeting the highest international standards for biologic manufacturing. The highly purified 150kDa neurotoxin is the only active ingredient in XEOMIN^®. It is produced by removing complexing proteins from botulinum toxin type A, using XTRACT^® purification technology developed by Merz Pharma GmbH & Co. KGaA.

XEOMIN^® is the registered trademark of Merz Pharma GmbH & Co. KGaA.

¹ European SmPC (Summary of product characteristics), 2021-08-31

² Berweck et al. Neurology. 2021 Aug 2:10.1212/WNL.0000000000012573. doi: 10.1212/WNL.0000000000012573.

Press Contact
Agnes Tesch

Merz Therapeutics, a business of Merz Pharmaceuticals GmbH
Global Communications
+49 69 1503 2129
Agnes.tesch@merz.de