FDA OKs OnabotulinumtoxinA for Upper Limb Spasticity in Children

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.

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.

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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.

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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.

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"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.

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"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.

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