Health Canada Approves XEOMIN® (incobotulinumtoxinA) for the Treatment of Adults with Post-stroke Lower Limb Spasticity in the Ankle and Foot.

tamiah312 December 17, 2024

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Health Canada Approves XEOMIN® (incobotulinumtoxinA) for the Treatment of Adults with Post-stroke Lower Limb Spasticity in the Ankle and Foot.

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via Business Wire

Published on December 17, 2024 • 5 minutes read

BURLINGTON, Ontario — Merz Therapeutics, a Merz Group business and leader in the field of neurotoxins, today announced that Health Canada has approved XEOMIN^® (incobotulinumtoxinA) for the treatment of post-stroke low spasticity involving the ankle and foot in adults.

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“This approval means that adult patients who have had a stroke and are suffering from leg and foot problems will now have a safe and effective treatment option,” explains Michael Stone, Country Manager, Canada for Merz Therapeutics. “With this label extension, healthcare providers can now use XEOMIN to pursue holistic and individualized treatment goals for their patients.”

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Addressing multiple patterns of spasticity with XEOMIN

Strokes are the main cause of pain caused by upper motor neuron damage, which produces an abnormal increase in muscle tone. In Canada, 109,000 people a year have a stroke¹and 25% to 43% of stroke survivors experience grief within a year². XEOMIN with the active ingredient incobotulinumtoxinA injected intramuscularly to reduce the abnormal increase in muscle tone. With a new permission, XEOMINit can be used with 600 units in the upper and lower limbs together, which enables health professionals trained in Canada to manage both regions together or individually, adjusting the dose according to the patient’s needs and travel goals. The safety results were similar to previous studies in adults and consistent with the known safety profile of XEOMIN. The most common adverse events affecting ≥1% of patients were nasopharyngitis, pharyngitis, tinea pedis, muscle weakness, epilepsy, falls, eczema, dehydration, and blurred vision.

“Foot and ankle posture problems are the most common posture problems seen in the lower limb in elderly patients following a stroke. They usually appear to have an equinovarus deformity, which means the foot turns downward and inwards at these joints,” said Professor Lalith Satkunam, from Glenrose Rehabilitation Hospital, Edmonton, Alberta. “Lower limb stiffness can limit sleep and interfere with patients’ daily lives, so this recent approval of XEOMIN gives health care professionals, like me, the ability to comprehensively treat many areas of spasticity.”

“The ability to simultaneously treat both upper and lower post-stroke spasticity in adults with botulinum toxin using a combined dose of 600 units makes it an important tool in our clinical setting,” shared Dr. Jehane Dagher, Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM), Montreal, Quebec.

A label extension built on robust data

Canada is the third country to approve XEOMIN for the treatment of lower limbs based on data from the Japanese study (J-PLUS), which investigated the effects of XEOMIN on spasticity in Japanese stroke survivors. “Health Canada’s decision to extend the area used by XEOMIN reaffirms the quality and robustness of our Japanese data and is proof of our belief that bringing better results to more patients should be an international effort,” said Stefan Albrecht, Chief Scientific and Medical. CEO at Merz Therapeutics. “We were able to uncover clinical data generated in Japan to support the application with Health Canada based on large datasets from multiple clinical trials and definitive efficacy data from Japanese research.” Previously, data from J-PLUS were also included in application packages for lower extremity treatment label extensions in the United Kingdom and Switzerland.

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This is the sixth therapeutic index of XEOMINIn Canada, which was first approved by Health Canada in 2009 for the treatment of disorders of hypertonicity of the seventh nerve such as blepharospasm, including significant blepharospasm and hemifacial spasm in adults, to reduce subjective and objective symptoms of cervical dystonia (i -spasmodic torticollis) in adults, and treatment of upper limb spasticity in adults.³ XEOMIN was also licensed for adult patients with chronic sialrhea in 2020 and pediatric patients (2-17 years weighing 12 kg or more) in 2022.

References

1. Holodinsky JK, Lindsay P, Yu AYX, Ganesh A, Joundi RA, Hill MD. Estimating the Number of Hospital or Emergency Department Presentations for Stroke in Canada. Is J Neurol Sci. 2023;50(6):820-825. doi:10.1017/cjn.2022.338

2. Effects of Stroke, Physcal Effects, Spasticity. 30 May 2023, www.stroke.org/en/about-stroke/effects-of-stroke/physical-effects/spasticity. Accessed on 4 Nov. 2024.

3. XEOMIN^® Product Monograph. Merz Pharma Canada Ltd. December 11, 2024.

About XEOMIN^®

XEOMIN^® (incobotulinumtoxinA) is a prescription drug that is injected into muscles or glands and is used to treat adult and pediatric patients with chronic drooling (sialorrhea), eyelid spasm (blepharospasm) and spasm on one side of the face (hemifacial spasm), neck spasticity (spasmodic torticollis), upper limb spasticity in adults and post-stroke lower limb spasticity including ankle and foot in adults.

For more information, please see XEOMIN^® full Product Monograph.

About Merz Therapeutics

Merz Therapeutics GmbH is dedicated to improving the lives of patients around the world. Through its relentless research, development, and culture of innovation, Merz Therapeutics strives to provide unmet patient needs and achieve better outcomes. Merz Therapeutics seeks to address the unique needs of people with mobility issues, neurological conditions, liver disease, and other health conditions that significantly affect patients’ quality of life.

Merz Therapeutics is based in Frankfurt am Main, Germany and is represented in more than 90 countries, with a Canadian subsidiary based in Burlington, Ontario, Canada. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company dedicated for 116 years to the development of innovations that serve unmet patient and customer needs.

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Please visit www.merztherapeutics.com

About Merz

The Merz Group is a global, diversified healthcare company based in Frankfurt, Germany. Family-owned for over 116 years, the company is distinguished by its commitment to innovation, long-term vision, and focus on profitable growth. The 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 financial year 22/23) in 28 countries around the world.

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