Botox Approved for Treatment of Upper Limb Spasticity in Pediatric Patients

The US Food and Drug Administration (FDA) has approved Allergan’s supplemental biologics application (sBLA) for onabotulinumtoxinA (Botox) for treatment of upper limb spasticity in pediatric patients between the ages of 2 and 17. 



The FDA approval, which was announced by Allergan on Friday, is based and at a from 2 Phase 3 studies that evaluated the safety and efficacy of onabotulinumtoxinA in more than 200 pediatric patients with upper limb spasticity. 


"Because spasticity is particularly debilitating to growing children, it requires ongoing care,” said Mark Gormley, Jr., MD, pediatric rehabilitation medicine specialist with the Gillette Children’s Specialty Healthcare - St. Paul. “Botox has a well-established safety and efficacy profile and I believe it will be an important treatment option in helping successfully manage upper limb spasticity in children and adolescents."




The approved recommended dosage of onabotulinumtoxinA per treatment session is 3 units per kilogram to 6 unites per kilogram divided among affected muscles of the upper limb. Total dose among pediatric patients should not exceed 8 units per kilogram body weight or 300 units, whichever is lower, during a 3-month period.

Treatment with onabotulinumtoxinA is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed. It is not known whether onabotulinumtoxinA is safe or effective for other types of muscle spasms. 



The FDA is currently reviewing an additional sBLA for the use of onabotulinumtoxinA in the treatment of lower limb spasticity in pediatric patients. That decision is expected in the fourth quarter of this year. OnabotulinumtoxinA has a previous approval for treatment of estrabismus or blepharospasm in patients 12 years and older. 



"This FDA approval is special to all of us at Allergan because we can now provide children and their caregivers an advancement in pediatric care with Botox,” said David Nicholson, chief research and development officer at Allergan. “This milestone underscores our constant focus on innovation and builds on our 30-years of research and development efforts with Botox since FDA approval of blepharospasm and strabismus in 1989. We also look forward to the FDA's decision on pediatric lower limb spasticity and continuing to serve our patients globally."