Allergan’s Botox gets FDA approval for new indication
Allergan has received the Food and Drug Administration’s clearance for Botox (onabotulinumtoxinA) for the treatment of pediatric patients ages 2-to-17 years old with upper limb spasticity.
Botox, which is injected into muscles, is indicated to treat increased muscle stiffness in children 2 to 17 years of age with upper limb spasticity, and to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older.
“Watching a child suffering with any degree of upper limb spasticity is very difficult,” said David Nicholson, Allergan chief research and development officer. “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.”
“Pediatric upper limb spasticity is a significant concern and can negatively impact a child’s development and quality of life,” said Paul Mark Gormley, Jr., pediatric rehabilitation medicine specialist, Gillette Children’s Specialty Healthcare-St. Paul. “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.”
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