Health Canada Approves XEOMIN (IncobotulinumtoxinA) for Treatment of Post-Stroke Lower Limb Spasticity

Published: 19 Dec 2024

Author: Precedence Research

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XEOMIN® (incobotulinumtoxinA) got approval from Health Canada for treating spasticity in adults in the post-stroke lower limb. A significant step in healthcare history for Canada, this is yet another vital milestone in the wider application for XEOMIN, through which healthcare providers can eventually treat upper and lower limb spasticity in the same patient by combining the two limbs into a total of 600 units. With this label expansion for XEOMIN, its basal role is now underpinned as a fundamental tool in neurological rehabilitation improvement of ambulation to a reduction in pain. Every year, more than 109,000 strokes adversely affect Canadians. Of this number, a greater percentage of survivors become spastic one year after their stroke. This would be the sixth therapeutic use added to XEOMIN in Canada after others such as cervical dystonia, upper limb spasticity, and chronic sialorrhea.

Spasticity brought about by stroke physiologically affects around 109000 of Canadians every year with 25% to 43% of those who survived developing spasticity within a year of the incidence. XEOMIN is a novel therapy option for these patients and is effective in bringing about relief from conditions related to spasticity. XEOMIN is approved for use by adult patients with lower limb spasticity affecting the ankle and foot, thus providing a safe and efficacious option for treatment.

Benefits of XEOMIN in Comprehensive Spasticity Management

XEOMIN's new license now extends its indication for the treatment of spasticity in both upper and lower limbs to a total combined dose of 600 units, thus enabling the clinician to individualize doses for each patient. The benefits of the new product include: versatility, effectiveness in the reduction of hypertonicity, and a similar safety profile with mild side effects, such as upper respiratory infections and muscular weakness.

Clinical Perspectives on the Impact

Healthcare professionals emphasized the transformative potential of XEOMIN:

• Dr.Lalith Satkunam, from Glenrose Rehabilitation Hospital, Edmonton, noted, "Foot and ankle spasticity are the most common posture problems in stroke survivors. XEOMIN provides a full treatment modality for them."
• "Treating upper and lower limb spasticity simultaneously with a combined dose of 600 units is revolutionary in rehabilitation," said Dr. Jehane Dagher from the  Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM), Montreal, Quebec.

Robust Clinical Data from the J-PLUS Study

The endorsement of XEOMIN as an anti-spasticity agent in Canada was for evaluation under the J-PLUS study, which summarizes the results from a recruit of stroke survivors in Japan. Improvement in muscle tone and functionalities in lower limb spasticity was significant. The approval and others, including the UK and Switzerland, corroborate the study's robustness. The very first approval of XEOMIN was in 2009 for the treatment of hypertonicity disorders such as blepharospasm and cervical dystonia. Thereafter, it has been approved for chronic sialorrhea in adults and pediatric spasticity for 2 to 17-year-old children.

A Global Commitment to Better Outcomes

Stefan Albrecht, Chief Scientific and Medical Officer at Merz Therapeutics has remarked that approval by Health Canada for XEOMIN for post-stroke lower limb spasticity is simply a milestone towards neurological rehabilitation. The company would support XEOMIN in other territories through research and ongoing trials. Thereby, XEOMIN has a good clinical foundation and wide therapeutic scope which set a benchmark in spasticity management for a safe and effective treatment option for stroke survivors.