FDA Approves Injection for Treating Pediatric Lower Limb Spasticity

The FDA has approved an abobotulinumtoxinA (Dysport) injection for treating children aged 2 or older who have pediatric lower limb spasticity. This injectable form of botulinum toxin type A (BoNT-A), which is derived from Clostridium bacteria that produce BoNT-A, is the first botulinum toxin approved to treat pediatric lower limb spasticity. 

The approval was based on results from a double-blind, prospective Phase 3 study of 235 pediatric patients who were randomized to receive abobotulinumtoxinA  (158 patients) or placebo (77 patients) injected into the gastrocnemius-soleus muscle complex. 

Most patients had a response that lasted 16 to 22 weeks or longer, according to Claude Bertrand, Executive Vice President, Research and Development, Chief Scientific Officer of Ipsen, the company who makes the drug. 

However, botulinum products, including abobotulinumtoxinA, have a Boxed Warning about potentially life-threatening adverse effects. The toxin may cause swallowing and breathing difficulties similar to symptoms of botulism if it spreads from the injection area to other parts of the body. 

—Lauren LeBano 

Reference 

Ipsen Announces FDA Approval of Dysport® (abobotulinumtoxinA) for Injection for the Treatment of Lower Limb Spasticity in Children Aged Two and Older [press release]. Paris, France: Business Wire; August 1, 2016.