14 March 2018 - Merz North America announced today that the U.S. FDA has accepted for filing a supplemental biologics license application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson’s disease or other neurologic disorders in adult patients. 

The sBLA is based on a Phase III study, which met both of its co- primary endpoints for subjects administered 100 U incobotulinumtoxinA by achieving statistically significant change in unstimulated salivary flow rate, and in the subjects’ Global Impression of Change Scale. 

The FDA has set a Prescription Drug User Fee Act action date in Q4 2018, and if approved, has the potential to make Xeomin the first neurotoxin with this indication in the U.S.

Read Merz press release