Merz's Xeomin for adults gets FDA approval
Merz North America has received the green light from the Food and Drug Administration for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. The condition can occur from difficulty retaining saliva inside the mouth, issues with swallowing and from problems controlling facial muscles.
Xeomin is the first and only neurotoxin with this approved indication in the United States.
“Until now, there has not been an FDA approved treatment for this debilitating condition,” Merz vice president and U.S. head of neurosciences Kevin O’Brien, said. “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.
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, and in adult patients and in 2015 for upper limb spasticity in adult patients.
Xeomin is the first and only neurotoxin with this approved indication in the United States.
“Until now, there has not been an FDA approved treatment for this debilitating condition,” Merz vice president and U.S. head of neurosciences Kevin O’Brien, said. “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.
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, and in adult patients and in 2015 for upper limb spasticity in adult patients.