FDA Approves Xeomin

Merz North America announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. XEOMIN is the first and only neurotoxin with this approved indication in the U.S.

"Until now, there has not been an FDA approved treatment for this debilitating condition," said Kevin O’Brien, Vice President and U.S. Head of Neurosciences, Merz North America. "This approval represents a significant milestone in addressing the unmet needs for more than 600,000 adults who suffer from chronic sialorrhea, and underscores our commitment to improving the lives of those living with movement disorders."

Sialorrhea is a common symptom among patients who suffer from neurological disorders including Parkinson's disease, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP) or who have experienced a stroke. The condition can occur from difficulty retaining saliva inside the mouth, issues with swallowing and from problems controlling facial muscles.

The FDA granted this application a priority review designation upon acceptance. Priority reviews are granted to drugs that will potentially provide significant improvements in the safety and effectiveness of the treatment, diagnosis or prevention of serious conditions.

Xeomin was approved by the FDA for adult patients with sialorrhea and 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).

This is the fourth neurological indication for Xeomin, which was first approved by the FDA in 2010 for the treatment of cervical dystonia and blepharospasm (in patients previously treated with onabotulinumtoxinA) in adult patients and later in 2015 for upper limb spasticity in adult patients.

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