RALEIGH, N.C. — Merz North America announced 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. Xeimin 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.