Ipsen Biopharmaceuticals announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in patients aged ≥2 years. This approval marks Dysport as the first FDA-approved botulinum toxin for this indication.
The FDA approval was based on data from a Phase 3 randomized, multi-center, double-blind, placebo-controlled, international study (n=235) in patients aged 2–17 years with lower limb spasticity due to cerebral palsy causing dynamic equinus foot deformity. Patients were randomized to Dysport 10U/kg/leg, Dysport 15U/kg/leg, or placebo.
The data showed that patients treated with Dysport demonstrated statistically significant improvement in co-primary efficacy assessments: mean change from baseline in Modified Ashworth Scale (MAS) in ankle plantar flexor muscle tone and mean Physician’s Global Assessment (PGA) response to treatment score at Weeks 4 and 12. At Week 4, the mean treatment difference in MAS vs. placebo were –0.5 for placebo, –0.9 for Dysport 10U, and –1.0 for Dysport 15U (P<0.05). At Week 4, the mean treatment difference vs. placebo were –0.5 for placebo, –0.8 for Dysport 10U, and –1.0 for Dysport 15U.
A statistically significant improvement was seen on the mean PGA response to treatment score at Week 4 with a mean treatment difference of 0.7 for placebo, 1.5 for Dysport 10U, and 1.5 for Dysport 15U (P<0.05). At Week 12, the treatment difference vs. placebo were 0.4 for placebo, 0.8 for Dysport 10U, and 1.0 for Dysport 15U (P<0.05).
Dysport is already approved to treat adults with cervical dystonia and for the treatment of upper limb spasticity, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors. It is supplied as 300 Unit and 500 Unit strengths in single-use vials.
For more information call (866) 837-2422 or visit Dysport.com.