Merz Therapeutics, part of the Merz Group and a leader in neurotoxin therapies, today announced that Health Canada has approved XEOMIN® (incobotulinumtoxinA) for the treatment of post-stroke lower limb spasticity affecting the ankle and foot in adults.This approval provides a significant advancement in treatment options for adult stroke survivors experiencing this common and debilitating condition.
Michael Stone, Country Manager for Merz Therapeutics in Canada, emphasized the importance of this approval: “This approval means that adult patients who have suffered a stroke and are experiencing lower limb spasticity in the ankle and foot will now have a safe and effective treatment option. With this label extension, healthcare providers can now use XEOMIN to pursue more comprehensive and individualized treatment goals for their patients.”
Spasticity, often resulting from stroke-induced damage to the upper motor neuron, leads to an abnormal increase in muscle tone. In Canada, approximately 109,000 people suffer strokes annually, and 25% to 43% of stroke survivors experience spasticity within a year. XEOMIN, which contains the active ingredient incobotulinumtoxinA, is injected intramuscularly to reduce the abnormal muscle tone caused by spasticity. With this new approval, XEOMIN can now be administered in doses up to 600 units for both upper and lower limbs combined. This allows healthcare professionals in Canada to treat multiple regions of spasticity at once, adjusting the dosage based on patient needs and mobility goals.
The safety profile of XEOMIN remains consistent with previous studies, with the most common adverse reactions affecting 1% or more of patients being nasopharyngitis, pharyngitis, tinea pedis, muscular weakness, epilepsy, falls, eczema, dehydration, and blurred vision.
Professor Lalith Satkunam from Glenrose Rehabilitation Hospital in Edmonton explained, “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, where the foot turns downwards and inwards. Lower limb spasticity can limit ambulation and impact patients’ daily lives, so this latest approval for XEOMIN provides healthcare professionals with the ability to treat multiple areas of spasticity comprehensively.”
Dr. Jehane Dagher from the Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM) in Montreal also praised the approval, stating, “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.”
The approval of XEOMIN for lower limb spasticity is based on strong clinical evidence, including data from the J-PLUS study, a Japanese trial that explored the effects of XEOMIN on spasticity in stroke survivors. This data has also supported similar approvals in the United Kingdom and Switzerland. Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics, noted, “Health Canada’s decision to extend XEOMIN’s application highlights the robustness of our Japanese data and underscores our commitment to improving patient outcomes globally.”
XEOMIN is now approved for six therapeutic indications in Canada. Since its initial approval in 2009, it has been authorized for various conditions, including hypertonicity disorders, cervical dystonia, upper limb spasticity, chronic sialorrhea, and pediatric indications. With this latest approval, XEOMIN continues to expand its role in improving the lives of those affected by spasticity and related conditions.
