MERZ Obtains New Indication Approval from FDA
Last week, MRA Member Merz North America announced the FDA approved its 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. and received a priority review designation from the FDA at the time of its application acceptance in March.
“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 (above), 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.