15 March 2018 - With this approval, Dysport Therapeutic now has the broadest label of all approved botulinum neurotoxins for spasticity, which includes both upper and lower limb spasticity in adults, as well as lower limb in children.

Ipsen Biopharmaceuticals Canada today announced that Health Canada has approved Dysport Therapeutic (abobotulinumtoxinA) for the symptomatic treatment of focal spasticity affecting the lower limbs in adults.

Regulatory approval of Dysport Therapeutic for the treatment of lower limb spasticity in adults was evaluated in a prospective, Phase III, randomised, multi-centre, double-blind, placebo-controlled study that included 385 patients (255 Dysport Therapeutic and 130 placebo) with lower limb spasticity, and in its open label extension study. Patients had lower limb spasticity (Modified Ashworth Scale (MAS) score ≥2 in the affected ankle joint for toxin naive patients or MAS score ≥3 in the affected ankle joint for toxin non-naive patients at least 4 months since the last botulinum toxin injection in the affected lower limb) and were at least 6 months post-stroke or post-traumatic brain injury.

Read Ipsen press release