FDA approves Xeomin (incobotulinumtoxinA) for upper limb spasticity- Merz Pharma

Merz Pharma has announced that Xeomin (incobotulinumtoxinA) has received FDA approval for the treatment of upper limb spasticity (ULS) in adult patients. In clinical studies, treatment with Xeomin for adult ULS resulted in statistically and clinically significant improvements in muscle tone, with a safety profile similar to that observed for other Xeomin indications.

The safety and efficacy of Xeomin in the treatment of adult upper limb spasticity was evaluated in multiple Phase III clinical studies in more than 400 patients with ULS. The approval is based on results of a randomized, multicenter, placebo-controlled trial showing significant improvements in two co-primary outcome parameters: muscle tone (Ashworth Scale score) and the Investigator�s Global Impression of Change of the Primary Target Clinical Pattern (PTCP) at Week 4. Both showed statistical significance. The trial also met a key secondary outcome measure, in which subjects with an improvement at least 1 on the Ashworth Scale at Week 4 were classified as responders. Treatment related adverse events were reported for 3.8% and 1.9% of subjects treated with Xeomin and placebo, respectively. The most commonly observed adverse reactions (incidence at least 2% of patients and greater than placebo) for Xeomin were seizure (3%), nasopharyngitis (2%), dry mouth (2%), and upper respiratory tract infection (2%).