Posted by Michael Wonder on 26 Sep 2019
Ipsen announces FDA approval of Dysport (abobotulinumtoxinA) for the treatment of upper limb spasticity in children, excluding cerebral palsy
26 September 2019 - Dysport is the first and only FDA approved botulinum toxin for treatment of both paediatric upper and lower limb spasticity.
Ipsen Biopharmaceuticals announced today that the US FDA has expanded the use of Dysport (abobotulinumtoxinA) for injection to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy. This approval makes Dysport the first botulinum toxin approved by the FDA for both paediatric spasticity indications, following the previous approval to treat children with lower limb spasticity aged two and older received in July 2016.
The approval is based on a Phase 3 study with children aged 2 to 17 years old being treated for upper limb spasticity.
