"Merz Therapeutics, a business of Merz Group and a leader in the field of neurotoxins, 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.”
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 stroke, and 25% to 43% of stroke survivors experience spasticity within a year. 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.
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. 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.
Xeomin (incobotulinumtoxinA) is a prescription medicine that is injected into muscles or glands and used to treat adults and paediatric 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.
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