Xeomin Receives Expanded Approval for Upper Limb Spasticity

August 19, 2020 – The U.S. FDA has approved an expanded indication for Xeomin® (incobotulinumtoxinA) intramuscular or intraglandular injection, manufactured by Merz Pharmaceuticals. The product is now indicated to treat upper limb spasticity in pediatric patients who are ages two through 17 years, excluding upper limb spasticity caused by cerebral palsy. Previously, the product was approved to treat upper limb spasticity in adults only.

Upper limb spasticity occurs when the nervous system is unable to properly communicate with the muscles of the arms. This can lead to stiff, contracted muscles and uncontrollable movements, as well as intermittent and chronic pain. Causes include neurological disease, such as multiple sclerosis and cerebral palsy, as well as brain and spinal cord injury, such as from a stroke, illness, or accident.

In a clinical study, Xeomin delivered sustained improvements in muscle tone and was found to have a similar safety profile in pediatric patients as that seen in adults. Recommended dosing varies based on the muscles involved. The maximum dose per upper limb is 8 units/kg of body weight, not to exceed 200 units total. Xeomin is administered by a healthcare professional via intramuscular injection, with at least 12 weeks between treatments.

A black box warning cautions that there is a risk of distant spread of effects with all botulinum toxin products, including Xeomin. Symptoms can occur hours to weeks after injections and can lead to life-threatening difficulties with swallowing or breathing. The risk is highest in children treated for spasticity.

Xeomin first received FDA approval in 2010. It is also indicated to treat chronic sialorrhea, cervical dystonia, and blepharospasm in adults, and has a cosmetic indication to temporarily improve the appearance of moderate to severe glabellar lines. Although clinical studies show that Xeomin is safe and effective for the treatment of spasticity caused by cerebral palsy, it has not been approved for CP-associated spasticity due to marketing exclusivity granted to other botulinum toxin products.