Regulatory Affairs

FDA extends Dysport use for lower limb spasticity in adults

PBR Staff Writer Published 19 June 2017

The US Food and Drug Administration (FDA) has approved Ipsen’s Dysport (abobotulinumtoxinA) injection to treat lower limb spasticity in adults.

Dysport was approved in July 2015 to treat upper limb spasticity in adults. In July 2016, it was approved for the treatment of pediatric patients with lower limb spasticity aged two and older.

The latest approval was based on data from a phase III, multi-center, prospective, double-blind, randomized, placebo-controlled study in 381 adults treated with Dysport 1000 units, Dysport 1500 units or placebo following a stroke or traumatic brain injury.

There was an improvement in muscle tone at the ankle joint, as assessed by the change from baseline in the Modified Ashworth Scale (MAS) at Week 4 (P<0.05).  

Dysport 1500 Units injection was associated with a statistically significant improvement in muscle tone and spasticity at the ankle joint.

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 (about 20 weeks).

Ipsen said 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 an earlier injection has destroyed, but no sooner than 12 weeks after the previous injection.

Dysport is supplied as a lyophilized powder containing a form of botulinumtoxin type A (BoNT-A), which is isolated and purified from Clostridium bacteria producing BoNT-A. 

Ipsen executive vice-president of R&D, chief scientific officer Alexandre Lebeaut said: “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.”

Image: Ipsen Pharma Biotech. Photo: courteys of Xavier Boymond.