Dysport, manufactured by Ipsen Biopharmaceuticals Inc, a subsidiary of Ipsen SA, is now FDA-approved for injection for the treatment of lower limb spasticity in pediatric patients 2 years of age or older.
Dysport (abobotulinumtoxinA) is a type of botulinum toxin, and its approval was based on a clinical study that included 235 pediatric patients age 2 to 17 with lower limb spasticity due to cerebral palsy causing dynamic equinus foot deformity.
In the multicenter, double-blind, prospective, randomized, placebo-controlled study, 158 patients received Dysport and 77 received placebo, according to a media release from ipsen Biopharmaceuticals.
The release explains that those treated with Dysport® showed 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 Week 4 and Week 12. A majority of patients in the clinical study were eligible for retreatment between 16 and 22 weeks; however, some had a longer duration of response.
“This approval means that, for the first time, physicians have a FDA-approved botulinum toxin with recommended dosing guidance for the treatment of children 2 years of age and older with lower limb spasticity based on a large registrational study,” says Ann Tilton, MD, professor of clinical neurology, Chief, Section of Child Neurology, Louisiana State University School of Medicine, in the release.
[Source(s): Ipsen Biopharmaceuticals Inc, PR Newswire]