FDA expands approval for Dysport (abobotulinumtoxinA) for spasticity in adults- Ipsen Biopharmaceuticals
Ipsen Biopharmaceuticals announced that the FDA has expanded the approved use of Dysport (abobotulinumtoxinA) for injection for the treatment of spasticity in adults, based on its supplemental Biologics License Application (sBLA) in lower limb spasticity. 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 two and older, making it the first and only botulinum toxin that the FDA approved for this indication.
The expanded approval is based on 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 degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of Dysport and muscles to be injected. Repeat Dysport treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection.
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