EU approves Xeomin for sialorrhea due to neurological conditions.

Merz announced the European approval of Xeomin (incobotulinumtoxinA) for the symptomatic treatment of chronic sialorrhea (drooling) due to neurological disorders in adult patients. Xeomin is the first and only neurotoxin with this approved indication in the EU, which follows the US FDA approval in July 2018.

The approval of Xeomin for adult patients with sialorrhea by European authorities is based on a Phase III, randomized, double-blind, placebo-controlled, multicenter 184 patient trial. Both co-primary endpoints were successfully achieved. A statistically significant improvement was observed in change in unstimulated salivary flow rate (uSFR) and Global Impression of Change Scale (GICS), both at week four as compared to baseline pre-injection for subjects administered 100 U incobotulinumtoxinA vs. placebo (p=0.004 and p=0.002, respectively). GICS is a commonly used rating system for treatments of neurological disorders by clinicians. Overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported. Subjects enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).

Comment: This is the first approved indication in the EU and the fourth therapeutic indication for Xeomin, which was first introduced in 2005 in Germany and was approved in 13 EU member states in 2007 for the treatment of cervical dystonia and blepharospasm in adult patients. In 2009, Xeomin received approval for the treatment of upper limb spasticity in adult patients.