FDA approves Botox (onabotulinumtoxinA) for paediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy

Allergan

24 October 2019 - Approval marks 11th Botox therapeutic indication and comes 30 years after the first indications were approved.

Allergan today announced that the U.S. FDA approved the company's supplemental biologics license application for Botox for the treatment of paediatric patients (2 to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy (CP). 

This marks the 11th Botox therapeutic indication, having been approved for paediatric upper limb spasticity earlier this year. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs, and can interfere with movement. The severity can range from mild to severe muscle stiffness.

The FDA approval is based on a Phase 3 study evaluating the safety and efficacy of Botox in more than 300 paediatric patients aged two to 17 years old being treated for lower limb spasticity.

Read Allergan press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics