Pharma Focus Europe

XEOMIN® (IncobotulinumtoxinA) Receives Approval for New Therapeutic Use in Switzerland

Saturday, June 15, 2024

Merz Therapeutics, a division of the Merz Group specializing in neurotoxins, has recently obtained approval from Swissmedic, the Swiss Agency for Therapeutic Products, for XEOMIN® in treating focal spasticity of the lower limbs. This approval complements its existing authorization for upper limb spasticity treatment, significantly expanding treatment options for spasticity sufferers in Switzerland.

Merz Therapeutics, highlighted the significance of this approval, stating, "The Swiss approval represents a crucial advancement for Merz Therapeutics in improving treatment outcomes for spasticity patients, aligning with our commitment to delivering better outcomes for more patients." He also noted the extension of UK approval last year, allowing for a unified approach to treating upper and lower limb spasticity across these two European countries, laying a solid foundation for future developments.

Spasticity arises primarily from strokes, characterized by damage to upper motor neurons causing heightened muscle tone. In Switzerland, approximately 16,000 people suffer strokes annually, with 10-38% of survivors developing spasticity, including an estimated 1,700 experiencing severe symptoms. XEOMIN®, containing incobotulinumtoxinA, is administered via intramuscular injection to reduce muscle tone. The new approval permits XEOMIN® to be used in combined treatments of up to 600 units for upper and lower limb spasticity, enabling tailored treatments by healthcare providers based on individual patient needs.

Merz Therapeutics Switzerland, expressed enthusiasm, saying, "This approval marks a significant milestone not only for Merz Therapeutics but, more importantly, for people living with spasticity and the healthcare professionals managing their care. XEOMIN®'s expanded treatment scope for upper and lower limbs offers new possibilities to achieve personalized treatment goals."

For combined upper and lower limb spasticity treatment, XEOMIN® initially allows up to 500 units, potentially increasing to 600 units for subsequent treatments, with recommended intervals of at least 12 weeks between treatments.

The approval of XEOMIN® for lower limb spasticity in Switzerland builds upon similar successful approvals in non-EU countries, leveraging robust international clinical data. Clinical evidence from Japan supported XEOMIN®'s approval for lower limb spasticity in adults by the PMDA/MHLW in 2021, subsequently contributing to its approval by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) in 2022.

XEOMIN® acts by reducing voluntary muscle contractions, achieving muscle relaxation through inhibition of acetylcholine release from nerve endings. It is formulated without complex-forming proteins, minimizing the risk of antibody formation. XEOMIN® is approved in over 75 countries for treating upper and lower limb spasticity, as well as conditions such as cervical dystonia, blepharospasm, hemifacial spasm, and sialorrhea.



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