Basking Ridge, NJ-based Ipsen Biopharmaceuticals announced Aug. 1 that the Food and Drug Administration (FDA) had given the nod to its abobotulinumtoxinA injection for treatment of pediatric lower limb spasticity in children aged 2 years and older. It’s the first FDA-approved botulinum toxin for treatment of pediatric lower limb spasticity, according to a company release.
The approval comes after an Ipsen-sponsored pivotal trial in cerebral palsy patients (aged 2 to 17 years) with lower limb spasticity causing dynamic equinus foot deformity. The trial, published in February in Pediatrics, showed that compared with placebo, treatment with Dysport produced significant improvements in ankle plantar flexor muscle tone and Physician’s Global Assessment response to treatment score four weeks and three months after injection.
Most study patients were eligible for re-injection between 16 and 22 weeks, though some had more durable responses.