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

Burlington, Ontario, December 17, 2024 — Merz Therapeutics, a business of Merz Group and a leader in the field of neurotoxins, today announced that Health Canada approved XEOMIN^® (incobotulinumtoxinA) for the treatment of post-stroke lower limb spasticity involving the ankle and foot in adults.

“This approval means that adult patients who have suffered from a stroke and are experiencing lower limb spasticity in the ankle and foot 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 utilize XEOMIN to pursue more comprehensive and individually ambitious treatment goals for their patients.”

Addressing multiple patterns of spasticity with XEOMIN

Strokes are the primary cause of spasticity resulting from damage to the upper motor neuron, producing an abnormal increase in muscle tone. In Canada, 109,000 people annually suffer a stroke¹, and 25% to 43% of stroke survivors experience spasticity within a year². XEOMIN with the active ingredient incobotulinumtoxinA is injected intramuscularly to reduce the abnormally increased muscle tone. With the new approval, XEOMIN can be administered in up to 600 units for upper and lower limbs combined, enabling qualified healthcare professionals in Canada to treat both regions together or individually, adjusting the dosage depending on patient requirements and mobility goals. The safety findings were similar to previous adult studies and in line with the known safety profile of XEOMIN. The most common adverse reactions affecting ≥1% of patients were nasopharyngitis, pharyngitis, tinea pedis, muscular weakness, epilepsy, fall, eczema, dehydration, and blurred vision.

“Foot and ankle spasticity are the most common posture problems seen in the lower limb in adult patients following a stroke. They typically present with an equinovarus deformity, which refers to the foot turning downwards and inwards in these limbs,” said Professor Lalith Satkunam, Glenrose Rehabilitation Hospital, Edmonton, Alberta. “Lower limb spasticity can limit ambulation and impede on patients’ daily lives, so this latest approval for XEOMIN provides healthcare professionals, like me, the ability to comprehensively treat multiple areas of spasticity.”

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

A label extension built on solid data

Canada is the third country to authorize XEOMIN for lower limb treatment based on data from a Japanese study (J-PLUS), which investigated the effects of XEOMIN on spasticity in Japanese stroke survivors. “Health Canada’s decision to extend XEOMIN’s area of application once again underlines the quality and robustness of our Japanese data and is a testament to our conviction that delivering better outcomes for more patients must be an international effort,” says Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics. “We were able to extrapolate the clinical data generated in Japan to support the application with Health Canada based on a larger dataset from multiple clinical trials and decisive efficacy data from a Japanese study.” Previously, data from J-PLUS had also been included in application packages for label extensions for lower limb treatment in the United Kingdom and Switzerland.

This is the sixth therapeutic indication for XEOMIN in Canada, which was first licensed by Health Canada in 2009 for the treatment hypertonicity disorders of the seventh nerve such as blepharospasm, including benign essential blepharospasm and hemifacial spasm in adults, to reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults, and for the treatment of upper limb spasticity in adults.³ XEOMIN was also licensed for adult patients with chronic sialorrhea in 2020 and for pediatric patients (age 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. Can J Neurol Sci. 2023;50(6):820-825. doi:10.1017/cjn.2022.338

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

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

About XEOMIN^®

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

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

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 Canada affiliate based in Burlington, Ontario, Canada. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated 116 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.

Press Contacts

Merz Therapeutics
Nicole Lovern
Corporate Communications
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(571) 442-9665
Nicole.Lovern@merz.com

Merz Therapeutics GmbH
Agnes Tesch
Global Communications
+49 69 1503 2129
agnes.tesch@merz.de

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