FDA approves new indication for Merz's Xeomin

German family-owned drugmaker Merz Pharma Group says its US subsidiary has received approval from the Food and Drug Administration for Xeomin (incobotulinumtoxinA) for the treatment of upper limb spasticity (ULS) in adult patients.

In clinical studies, treatment with Xeominfor adult ULS resulted in statistically and clinically significant improvements in muscle tone, with a safety profile similar to that observed for other Xeominindications.

“We know that each patient has unique needs, and this new indication for Xeomin (incobotulinumtoxinA) is a result of our long-term commitment to serving individuals living with movement disorders and spasticity,” said Glenn Block, vice president and head – US Neurosciences for Merz North America, adding: “We look forward to supporting the launch of Xeomin for adult upper-limb spasticity with forward-thinking strategies in product support, clinical education, and patient advocacy and engagement.“