BRIEF—Dysport data drives push for uptake and approvals

In the last two years, Ipsen (Euronext: IPN) has won approval to market Dysport as a treatment for lower limb spasticity in adults (abobotulinumtoxinA) in the USA and some European countries.

The French drugmaker continues to push for further approvals, and its case has been helped by the publication in Neurology of full results from a Phase III trial and an open-label extension study.

The international Phase III registration study led to the US Food and Drug Administration (FDA)  expanded approval of Dysport for injection for the treatment of spasticity in adults, based on its supplemental Biologics License Application in lower limb spasticity, in June this year. It has also been the basis for marketing authorization in other key markets, including the UK and Germany, in late 2016, and regulatory procedures are still ongoing in other countries.

Results showed the efficacy and safety of Dysport in adults with hemiparesis who experienced lower limb spasticity. In this population, a single administration reduced muscle tone, while repeated administration over a year was well-tolerated and improved both walking speed and likelihood of achieving community ambulation.

Alexandre Lebeaut, Ipsen’s chief scientific officer, said: “The results of the published this month in Neurology underline the significant clinical benefit for adult patients with lower limb spasticity
who received repeated injections of Dysport.

“Similar to what we observed in adults with upper limb spasticity, many of these patients experienced a duration of response between 12 to 16 weeks, and some patients even experienced a longer duration of response up to 20 weeks.”