Ipsen gains FDA approval for pediatric spasticity use of Dysport

The US Food and Drug Administration has approved French drugmaker Ipsen’s (Euronext: IPN) 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. Dysportis the first and only botulinum toxin approved by the FDA for this indication,”said Claude Bertrand, executive vice President, R&D, and chief scientific officer of Ipsen. “In our Phase III 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,” he noted.

First approved by the FDA in 2009 for both aesthetic use as an anti-wrinkle treatment and medically as a treatment for cervical dystonia, Dysport gained US approval for adult upper limb spasticity in July last year. Sales of Dysport reached 139.6 million euros ($156 million) for the first six months of this year.