Merz Therapeutics, a business of the Merz Group and a leader in the field of neurotoxins, received approval from Swissmedic, the national authorization and supervisory authority for drugs and medical products in Switzerland, for the use of XEOMIN for the treatment of focal spasticity of the lower limb. Previously, the approval included spasticity of the upper limb and has now been extended, enabling Merz Therapeutics to offer more individualized comprehensive treatment to people living with spasticity in Switzerland.
"The approval in Switzerland is an important next step for Merz Therapeutics, empowering us to maximize patient outcomes to deliver on our promise of 'Better Outcomes for More Patients'," says Stefan König, CEO Merz Therapeutics. "Building on last year's label extension in the United Kingdom, we can now offer combined upper and lower limb spasticity treatment to patients in two European countries. This represents another important step in the right direction and an excellent foundation which we will further build on," he explains.
More comprehensive treatment options
Strokes are the primary cause for spasticity caused by damage to the upper motor neuron, resulting in an abnormal increase in muscle tone. In Switzerland, 16,000 people annually suffer a stroke, and 10-38 of survivors experience spasticity within a year, 1,700 of which are estimated to be affected by severe spasticity.1 XEOMINwith the active ingredient incobotulinumtoxinA is injected intramuscularly to reduce the abnormally increased muscle tone. With the new approval, XEOMINcan be administered in up to 600 units for upper and lower limbs combined, allowing qualified healthcare professionals in Switzerland to treat the upper and lower limbs either separately or together, adjusting the dosage as needed.
Martin Künzel, Country Manager of Merz Therapeutics Switzerland: "This is fantastic news for us at Merz Therapeutics, but more importantly for people living with spasticity and healthcare professionals providing much-needed care. By combining treatment of the upper and lower limbs, XEOMIN now provides new treatment options that can help patients achieve their individual treatment goals."
The maximum dose of XEOMIN for the combined treatment of upper and lower limb spasticity per administration is 500 units for the first treatment and may be increased up to 600 units with repeated treatments. The dosing interval should be at least 12 weeks.
Building on strong international foundations
The approval for the use of XEOMIN for the treatment of focal spasticity of the lower limb in Switzerland marks the third of its kind in a non-EU country in recent times. In 2021, a data package was compiled based on clinical data on the Japanese population for the approval of lower limb spasticity in adults by the PMDA/MHLW in Japan. Subsequently, the same data was used as the basis for a submission package for the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, which came to a successful conclusion in 2022. Now, it has contributed to yet another approval from a non-EU authority.
References
1. Definition Spastik. Was ist Spastik, spastische Lähmung, Spasmus oder Spastizität? Merz Pharma (Schweiz) AG. https://www.spastik-info.ch/de/spastik-definition/ (Last access: 16 April 2024).
About XEOMIN
XEOMIN is effective by weakening the contraction of voluntary muscles. It relieves the muscle tone by inhibiting the release of a neurotransmitter called acetylcholine from the peripheral nerve endings. XEOMIN is free from complexing proteins and has a low risk of neutralizing antibody formation. XEOMIN is approved in more than 75 countries worldwide to treat patients with upper and lower limb spasticity, cervical dystonia, blepharospasm, hemifacial spasm, and sialorrhea.
About Merz Therapeutics
Merz Therapeutics GmbH is dedicated to improving the lives of patients around the world. With its relentless research, development, and culture of innovation, Merz Therapeutics strives to serve unmet patient needs and realize better outcomes. Merz Therapeutics seeks to address the unique needs of people who suffer from movement disorders, neurological 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 represented in more than 90 countries, with a North America affiliate based in Raleigh, North Carolina. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated 115 years to developing innovations that serve unmet patient and customer needs.
Please visit www.merztherapeutics.com.
About Merz
Merz Group is a global, diversified company in the healthcare sector based in Frankfurt, Germany. Family-owned for over 116 years, the company is distinguished by its commitment to innovation, long-term perspective, and focus on profitable growth. Merz Group includes the businesses Merz Aesthetics, Merz Therapeutics, Merz Consumer Care, Merz Real Estate, and Merz Financial Investments. The company employs 4,337 people (as of the 22/23 financial year) in 28 countries worldwide.
To learn more, please visit www.merz.com.
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Contacts:
Merz Therapeutics GmbH
Agnes Tesch
Global Communications
+49 69 1503 2129
agnes.tesch@merz.de
