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Ipsen announced that the U.S. Food and Drug Administration (FDA) has approved Dysport® (abobotulinumtoxinA) for injection for the treatment of pediatric lower limb (PLL) spasticity in children two years of age and older.
“This approval in the US is a milestone in the treatment of pediatric lower limb spasticity, a condition that greatly impacts both children two years of age and older living with this form of spasticity and their caregivers. Dysport® is the first and only botulinum toxin approved by the FDA for this indication,” said Claude Bertrand, Executive Vice President, Research and Development, Chief Scientific Officer, Ipsen. “In our Phase 3 pivotal study, the majority of patients achieved a response lasting 16 to 22 weeks and sometimes longer. Dysport® is the only toxin to provide an FDA-approved dose range for the targeted muscles.”
Dysport® and all botulinum toxin products have a Boxed Warning which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism.
Those symptoms include swallowing and breathing difficulties that can be life-threatening.
“The approval of abobotulinumtoxinA means that, for the first time in the USA, physicians have an FDA-approved botulinum toxin and recommended dosing and administration guidance for the treatment of children from two years of age and older with lower limb spasticity,” said Mauricio R. Delgado M.D., Professor of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center and
The U.S. principal investigator of the Phase III trial. “This approval is based on data coming from worldwide studies conducted on several continents. Results were published in the journal Pediatrics1 confirming that we have conducted a pivotal study in this field. .”
