The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumtoxinA; Merz Pharmaceuticals) for the treatment of chronic sialorrhea in patients aged 2 years and older. Previously, Xeomin was only approved for chronic sialorrhea in adults.
The sBLA approval was based on data from a double-blind, placebo-controlled phase 3 study evaluating the efficacy and safety of Xeomin in 216 patients aged 6 to 17 years with chronic sialorrhea associated with cerebral palsy, other genetic or congenital disorders, or traumatic brain injury. Patients received either Xeomin according to body weight (up to 75 Units) or placebo into the parotid and submandibular glands using ultrasound guidance. An additional 35 patients aged 2 to 5 years received open-label treatment with Xeomin.
The co-primary end points in patients aged 6 to 17 years were the change in unstimulated Salivary Flow Rate (uSFR) and the carer’s Global Impression of Change Scale (GICS) score from baseline to week 4.
Results showed that Xeomin was associated with statistically significant reductions in uSFR (-0.14 vs -0.07; P =.0012) and improvements in GICS (0.91 vs 0.63; P =.032) at week 4 compared with placebo. Additionally, the improvements in chronic sialorrhea increased with each injection cycle. Efficacy in patients aged 2 to 5 years was extrapolated from the finding in patients aged 6 to 17 years.
As for safety, the most common adverse reactions reported among patients aged 6 to 17 years were bronchitis, headache, nausea, and vomiting. The most common adverse reaction among patients aged 2 to 5 years was nasopharyngitis.
Commenting on the approval, Elizabeth Moberg-Wolff, MD, Pediatric Rehabilitation Medicine Associates, said: “It’s estimated that 300,000 children in the US suffer from chronic drooling due to cerebral palsy or brain injury, but this approval provides them a safe and efficacious treatment option that they can use long-term with low probability they’ll build up an immunity to it with repeated use.”
Xeomin is also indicated for upper limb spasticity, cervical dystonia, blepharospasm and for the temporary improvement in the appearance of glabellar lines associated with corrugator and/or procerus muscle activity.
- FDA approves pediatric indication for Xeomin® (incobotulinumtoxinA) for the treatment of chronic sialorrhea. [press release]. Raleigh, NC: Merz Therapeutics; December 21, 2020.
- Xeomin [package insert]. Raleigh, NC: Merz Pharmaceuticals; 2020.