Officials with the FDA have approved Allergan’s supplemental biologics application (sBLA) for onabotulinumtoxinA (Botox) for the treatment of children, ages 2 to 17 years, with upper limb spasticity.1

The drug was previously granted a 6-month Priority Review by the FDA. The agency also is reviewing an additional sBLA for the use of onabotulinumtoxinA to treat children with lower limb spasticity, for which a decision is expected later this year.1

Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke, which is a group of disorders affecting one's ability to move and maintain balance and posture, according to Allergan.1

"Watching a child suffering with any degree of upper limb spasticity is very difficult," said David Nicholson, Chief Research and Development Officer, Allergan, in a prepared statement.1 "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. 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."

The FDA approved onabotulinumtoxinA (Botox) for treatment for adults’ lower limb spasticity in February 2016. It was initially approved by the agency in March 2010 for upper limb spasticity and later expanded to include treatment of 2 thumb muscles.2

The new FDA approval, for pediatric use, is based on data from two Phase 3 studies evaluating the safety and efficacy of onabotulinumtoxinA in over 200 pediatric patients with upper limb spasticity. These trials included a 12-week, double-blind study and a 1-year open-label extension study.1

The approved recommended dose per treatment session is 3 Units per kilogram to 6 Units per kilogram divided among affected muscles of the upper limb. The total dose in pediatric patients should not exceed 8 Units per kilogram body weight or 300 Units, whichever is lower, in a 3-month interval. Treatment with onabotulinumtoxinA is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed, according to Allergan.1

"Pediatric upper limb spasticity is a significant concern and can negatively impact a child's development and quality of life," said Mark Gormley, Jr. MD, Pediatric Rehabilitation Medicine Specialist, Gillette Children's Specialty Healthcare-St. Paul, in a prepared statement.1 "Because spasticity is particularly debilitating to growing children, it requires ongoing care. 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."

According to Allergan, onabotulinumtoxinA may cause serious adverse effects that can be life-threatening, such as problems swallowing, speaking or breather, and spread of toxin effects. The drug may also cause loss of strength, dizziness or eye problems, including double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes, drooping eyebrows. In addition, allergic reactions have been reported.1

Other adverse effects of onabotulinumtoxinA include dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and upper respiratory tract infection.1

  1. FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity . [news release]. Dublin, Ireland; June 21, 2019: Allergan website. Accessed June 21, 2019.
  2. Vermes K. Botox Approved for Treatment of Lower Limb Spasticity. Pharmacy Times. Published February 1, 2016. Accessed June 21, 2019.