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XEOMIN ® (IncobotulinumtoxinA) Secures Approval for Three Novel Therapeutic Indications in Australia

Thursday, November 23, 2023

Merz Therapeutics, a division of the Merz Group and a leading player in neurotoxin research, has secured approval from the Australian Therapeutic Goods Administration (TGA) for the use of XEOMIN® in treating chronic sialorrhea in both adults and children. This approval is a significant achievement as XEOMIN® becomes the first neurotoxin authorized for this purpose in the Australian market. Additionally, XEOMIN® has received approval for treating spasticity in the upper and lower extremities in children.

Sialorrhea, or uncontrolled salivation, is a common chronic condition resulting from neurological damage, often seen after a stroke or in children with chronic neurological impairments such as cerebral palsy. Individuals with sialorrhea struggle to control salivation, leading to challenges ranging from a diminished quality of life to potential health risks like suffocation and pneumonia.

In the past, only oral medications were approved for sialorrhea treatment, often associated with systemic side effects. Stefan König, CEO of Merz Therapeutics, expresses pride in contributing to enhanced treatment options, addressing a critical medical need and improving outcomes for more patients. The focus now shifts to raising awareness among healthcare professionals and providing proper training on XEOMIN® administration.

Andrea von der Lippe, Head of Region International Markets, expresses enthusiasm for expanding the treatment portfolio in Australia and anticipates further success in the broader Asia-Pacific (APAC) markets.

Regarding spasticity, Stefan Albrecht, Chief Scientific and Medical Officer, highlights the accomplishment of securing full approval for lower and upper extremity spasticity based on Merz's clinical trial data with XEOMIN®. This achievement allows healthcare professionals to comprehensively address spasticity in children.

Spasticity, characterized by speed-dependent increases in muscle tone and reflexes, is a chronic motor disorder often associated with cerebral palsy in children. XEOMIN® weakens voluntary muscle contractions by inhibiting the release of acetylcholine, a neurotransmitter, offering a treatment option that is free of complex-forming proteins and has a low risk of forming neutralizing antibodies. XEOMIN® is globally approved for various conditions, including upper and lower limb spasticity, cervical dystonia, blepharospasm, and sialorrhea, in over 75 countries.



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