Xeomin® Receives New Therapeutic Indication for the UK

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. 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).