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The US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application XEOMIN® (incobotulinumtoxinA).
The US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for Merz Therapeutics’ XEOMIN® (incobotulinumtoxinA) to treat patients aged 2 years and older who have upper limb spasticity, not including spasticity caused by cerebral palsy.1 It is the first approved pediatric indication for the drug. The FDA will also be deciding on an approval for incobotulinumtoxinA to treat pediatric cases of sialorrhea near the end of the year.
The approval was based on a Phase 3 study of 350 patients aged 2 to 17 years that looked at the safety and efficacy of incobotulinumtoxinA. Primary efficacy endpoints were changed from baseline on the 5-point Ashworth Scene and a 7-point Investigator’s Global Impression of Change Scale at the fourth week of treatment. The study illustrated sustained improvement in muscle tone in all upper limb muscle groups including flexed elbow, flexed wrist, forearm pronators, clenched fist, and thumb-in-palm. It also confirmed it was safe for bilateral treatment with up to 400 units per treatment. In clinical trials with 900 pediatric spasticity patients, no patient developed a clinical resistance to incobotulinumtoxinA. There was no evidence that higher dosing led to increased incidence of adverse reactions.
In the press release from Merz Therapeutics, Kevin O’Brien, President of North America said, “With the need for prolonged treatment, it is critical for children and adolescents with upper limb spasticity to have a long-term flexible treatment option to help manage their condition over time. At Merz Therapeutics, we designed our clinical trial program with 12 upper limb muscles to offer the most flexibility of any botulinum toxin, in order to offer patients, caregivers and doctors a safe and effective treatment option that meets the needs of pediatric patients.”
1. FDA approves first pediatric indication for xeomin® (incobotulinumtoxina) for the treatment of upper limb spasticity, excluding spasticity caused by cerebral palsy | Merz USA. Merz USA. Published August 19, 2020. Accessed August 19, 2020. https://www.merzusa.com/news/fda-approves-first-pediatric-indication-for-xeomin/.