Ipsen Biopharmaceuticals Inc announces that the US Food and Drug Administration has expanded its approval for the use of Dysport (abobotulinumtoxinA) via injection for the treatment of lower limb spasticity in adults.
In July 2015, Dysport was approved for the treatment of upper limb spasticity in adults. In July 2016, Dysport was approved to treat pediatric patients with lower limb spasticity aged 2 and older.
The recent approval was based on Ipsen Biopharmaceuticals’ supplemental Biologics License Application (sBLA) in lower limb spasticity, according to a media release from the company.
In a Phase III, multi-center, prospective, double-blind, randomized placebo-controlled study, adult patients treated with Dysport® following a stroke or traumatic brain injury showed improvement in muscle tone at the ankle joint, measured by the mean change from baseline on the Modified Ashworth Scale (MAS) at Week 4. The duration of response for the majority of patients within the study was between 12-16 weeks. In this study, some patients experienced a longer duration of response (approximately 20 weeks), the release explains.
“Adult patients who have developed spasticity as a result of a stroke, multiple sclerosis, cerebral palsy, spinal cord injury, or traumatic brain injury now have another option when seeking treatment that helps reduce the effects of the increased muscle tone in their lower extremities,” says Alexandre Lebeaut, MD, executive vice-president, R&D, chief scientific officer at Ipsen, in the release.
[Source(s): Ipsen Biopharmaceuticals Inc, Business Wire]