XEOMIN^® (incobotulinumtoxinA) receives a new therapeutic indication for the United Kingdom

Frankfurt, Germany, June 07, 2023 – Merz Therapeutics, a business of the Merz Group and a leader in the field of neurotoxins, received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the use of XEOMIN^® for the treatment of focal spasticity of the lower limb affecting the ankle joint. The approval, which previously included upper limb spasticity, has now been extended, enabling Merz Therapeutics to offer holistic support to people in the UK living with spasticity who require comprehensive treatment.

“The label extension in the UK is an important step for Merz Therapeutics and the patients that we serve. With the UK becoming the second market, following Japan, to grant approval for the treatment of lower limb spasticity, affecting the ankle joint, it establishes the UK as the pioneering European country in this area. This approval supports our strong commitment to bringing better outcomes to more patients,” says Stefan König, CEO Merz Therapeutics.

Enabling holistic treatment for people living with spasticity

Lower limb spasticity is a consequence of upper motor neuron damage as may occur following e.g. a stroke. Each year, around 41,800 people in England have a stroke that results in spasticity, approximately 66 % of which suffer from spasticity in the ankle.¹ XEOMIN^® with the active ingredient incobotulinumtoxinA is injected intramuscularly to improve tone. Appropriately qualified healthcare practitioners can now use XEOMIN^® to treat lower and upper limbs individually or concomitantly, adjusting the dosage as needed.

John Lambert, Country Manager of Merz Therapeutics UK & Ireland: “This new therapeutic indication supports an extension of the benefit XEOMIN^® can bring in the treatment of spasticity. We are very proud that we can now offer an alternative product to help patients in the UK.”

With the new therapeutic indication, the maximum dose of XEOMIN^® for the treatment of the lower limb is 400 units per injection visit. For the combined treatment of upper and lower limb spasticity, the maximum dose per administration is 500 units for the first injection and rising to 600 units for following injections. Accepting that patients should always be administered the lowest effective dose possible, with an increase in total dose patients can now be treated with XEOMIN^® for more patterns of spasticity simultaneously than before this new indication. The dosing interval should be at least 12 weeks. The therapeutic indication is based on trial data from Japan, where XEOMIN^® was also approved for treatment of the lower limb region in 2021.

Going forward, Merz Therapeutics can thus offer UK patients being treated for their spasticity a more holistic solution for their treatment.

¹ National Institute for Health and Care Excellence Draft scope for the proposed appraisal of botulinum toxin type A (Botox, Dysport and Xeomin) for treating upper and lower limb spasticity associated with stroke Issue Date: July 2014. Available at: https://www.nice.org.uk/guidance/gid-tag499/documents/spasticity-after-stroke-botulinum-toxin-type-a-draft-scope-for-consultation-prereferral-july-20142. (Accessed: 02 June, 2023).

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 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 more than 110 years to developing innovations that serve unmet patient and customer needs.

Please visit www.stage.merztherapeutics.com

About Merz

Merz Group is a global, diversified company with its headquarters in Frankfurt, Germany. Its commitment to innovation, long-term perspective, and focus on profitable growth depict the privately owned company that has been around for more than 110 years. Merz Group has the businesses Merz Aesthetics, Merz Therapeutics, Merz Lifecare, Merz Real Estate and Financial Investments. The company employs 3,969 people in 28 countries worldwide.

To learn more, please visit www.merz.com.