Ipsen  today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) in the treatment of upper limb spasticity in adult patients.

The regulatory filing was based on a clinical Phase III study involving nearly 250 adult patients with upper limb spasticity. The international, multi-center, double-blind, randomized, placebo- controlled trial compared the efficacy of Dysport versus placebo in hemiparetic patients following a stroke or brain trauma. The data showed that those treated with Dysport demonstrated a statistically significant (p<0.0001) improvement in muscle tone and a higher clinical benefit, versus placebo. The safety profile observed in the study was consistent with the known safety profile of Dysport.

For more details, go to: http://www.ipsen.com/wp-content/uploads/2014/11/28-11-2014-PR-Dysport-AUL-sBLA-FINAL.pdf