Posted by Michael Wonder on 20 Aug 2020
FDA approves first paediatric indication for Xeomin (incobotulinumtoxinA) for the treatment of upper limb spasticity, excluding spasticity caused by cerebral palsy
19 August 2020 - Xeomin was also granted FDA priority review for an application for paediatric sialorrhea, reinforcing Merz Therapeutics’ commitment to expanding options for paediatric patients.
Merz Therapeutics announced today that the U.S. FDA has approved a supplemental biologics license application for the first paediatric indication for Xeomin (incobotulinumtoxinA), for the treatment of patients aged 2 years and older with upper limb spasticity, excluding spasticity caused by cerebral palsy.
The FDA also granted Xeomin priority review for its application for the treatment of paediatric patients with sialorrhea with an expected decision this December.
