The sBLA was based on an international, multi-center, double-blind, randomized, placebo-controlled Phase III trial which included around 250 adult patients with upper limb spasticity.
The trial, which was conducted in the US, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary, compared the efficacy of Dysport versus placebo in hemiparetic patients following a stroke or brain trauma.
It was designed to evaluate the efficacy of Dysport compared to placebo in improving upper limb spasticity in hemiparetic patients following a stroke or a brain trauma.
The co-primary endpoints of the trial were the improvement of muscle tone in the treated upper limb measured by the Modified Ashworth Scale (MAS) and the clinical benefit for the patients evaluated by the Physician Global Assessment (PGA).
Ipsen chairman and chief executive officer Marc de Garidel said: "The filing of Dysport in adult upper limb spasticity is an important step in the reinforcement of the US neurology franchise.
"Upon FDA approval, Dysport will become a new treatment option for adults who suffer from upper limb spasticity in the US."
The company said that patients treated with Dysport showed a statistically significant improvement in muscle tone and a higher clinical benefit, versus placebo.