Posted by Michael Wonder on 02 Aug 2016
Ipsen announces FDA approval of Dysport (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in children aged two and older
1 August 2016 - First and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity.
Ipsen today announced that the U.S. FDA has approved Dysport (abobotulinumtoxinA) for injection for the treatment of paediatric lower limb spasticity in children two years of age and older.
“This approval in the US is a milestone in the treatment of paediatric 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.”
