FDA OKs Botox for Upper Limb Spasticity in Children

Megan Brooks


June 24, 2019

The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox, Allergan) to ease upper limb spasticity in children and adolescents aged 2 to 17 years, the company announced.

Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke.

Botox is the first neurotoxin to be approved in the United States to treat upper limb spasticity in pediatric patients, the company said in a news release.

"Pediatric upper limb spasticity is a significant concern and can negatively impact a child's development and quality of life," Mark Gormley Jr, MD, pediatric rehabilitation medicine specialist at Gillette Children's Specialty Healthcare–St. Paul in Minnesota, said in the release.

"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," said Gormley.

The FDA approved Botox for upper limb spasticity in children aged 2 years and older on the basis of data from two phase 3 safety and efficacy studies that enrolled more than 200 children. One study was a 12-week, double-blind study, and the other was a 1-year open-label extension study.

The recommended dose per treatment session is 3 – 6 units/kg divided among affected muscles of the upper limb. The total dose for pediatric patients should not exceed 8 units/kg body weight, or 300 units, whichever is lower, in a 3-month period.

Treatment with Botox is not a replacement for existing physical therapy or other rehabilitation that may have been prescribed, the company said.

The FDA granted the supplemental biologics license application (sBLA) for Botox for upper limb spasticity in children priority review status. The FDA is reviewing an additional sBLA for the use of Botox to treat children with lower limb spasticity; a decision is expected in the fourth quarter of this year, the company said.

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