9 January 2018 - Ipsen Biopharmaceuticals Canada today announced that Health Canada has approved Dysport Therapeutic (abobotulinumtoxinA) for the treatment of lower limb spasticity in paediatric patients two years of age and older. 

Those treated with Dysport Therapeutic showed statistically significant improvements across co-primary efficacy assessments including ankle plantar flexor muscle tone and response to treatment as measured by the Physician's Global Assessment (PGA) scale.2 Additionally, improvement in patient functionality including walking, balance, falling and endurance was observed at week 4 vs placebo as measured by Goal Attainment Scaling (GAS).

Regulatory approval of Dysport Therapeutic for the treatment of paediatric lower limb (PLL) spasticity was based on the results from an international Phase III study. The trial included 235 patients who were botulinum toxin naïve or previously treated with a botulinum toxin more than six months before study entry. The results showed those treated with Dysport Therapeutic (10 Units/kg/leg or 15 Units/kg/leg) demonstrated a statistically significant improvement in muscle tone measured by the Modified Ashworth Scale (MAS) as compared to placebo at week 4 and at week 12. Statistically significant improvement in the mean PGA score was also observed in both Dysport Therapeutic groups versus placebo at weeks 4 and 12. Statistically significant improvement in patient functionality, as measured by GAS was also observed at week 4 in both Dysport Therapeutic groups, whereas patients treated with placebo did not meet the expected level of improvement.

Read Ipsen Biopharmaceuticals press release