Xeomin Receives Expanded Indication

December 21, 2020 – The U.S. FDA has approved an expanded chronic sialorrhea indication for Xeomin® (incobotulinumtoxinA), manufactured by Merz Pharmaceuticals. Previously approved to treat the condition in adults, Xeomin is now indicated to treat chronic sialorrhea in pediatric patients who are at least two years of age.

Chronic sialorrhea, or excessive salivation, is often associated with conditions such as cerebral palsy and brain injury that can lead to poor control of facial and oral muscles. It can cause not only social strain for the patient and their family, but also physical complications such as dehydration, skin infections, difficulty breathing, and problems with eating and swallowing.

In a clinical study, patients treated with Xeomin had a significant improvement in symptoms at Week 4 compared to placebo. Treatment efficacy was sustained for at least 64 weeks, and symptom improvement versus baseline increased with each Xeomin injection received.

Recommended dosing for pediatric patients is based on body weight. Xeomin is administered as an intramuscular injection by a healthcare professional in a clinical setting. A black box warning cautions that the effects of Xeomin and other products containing botulinum toxins may spread beyond the area of injection hours to weeks after administration. This can lead to potentially fatal difficulties with swallowing and/or breathing.

First FDA approved in 2010, Xeomin is also indicated to treat upper limb spasticity, cervical dystonia, and blepharospasm. In addition, Xeomin holds a cosmetic indication to provide temporary improvement in the appearance of glabellar lines (a particular type of facial wrinkle).