Merz, a global leader in neurotoxin therapy, announced the European approval of Xeomin (incobotulinumtoxinA) for the symptomatic treatment of chronic sialorrhea (drooling) due to neurological disorders in adult patients. Xeomin is the first and only neurotoxin with this approved indication in the EU, which follows the US FDA approval in July 2018.
“At Merz, we are committed to bringing more good days to patients living with severe neurological disorders,” stated Stefan Brinkmann, Managing Director and Region Head EMEA at Merz. “We are confident that this new treatment option can help improve quality of life for sialorrhea patients, as well as for their relatives and caregivers. In many European countries, an approved medication for sialorrhea treatment in adults has not been available before now.”
Sialorrhea is a common but undertreated symptom accompanying neurological conditions such as Parkinson’s disease, acquired brain injury, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP) or stroke. Patients who experience sialorrhea suffer from a negative impact on activities of daily living, as well as social stigma and impaired quality of life. Left untreated, sialorrhea could be associated with perioral skin breakdown and pain around the mouth, choking, speech disorder, dehydration and aspiration pneumonia.
Xeomin is the first and only neurotoxin with this approved indication in the EU. This is the fourth therapeutic indication for Xeomin, which was first introduced in 2005 in Germany and was approved in 13 EU member states in 2007 for the treatment of cervical dystonia and blepharospasm in adult patients. In 2009, Xeomin received approval for the treatment of upper limb spasticity in adult patients. Xeomin is approved in 31 EU/EEA member states for the treatment of different neurological indications and is registered in more than 60 countries worldwide.