The US Food and Drug Administration (FDA) has accepted for review French pharmaceutical firm Ipsen's supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) to treat upper limb spasticity in adult patients.
Dysport is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium BoNT-A bacteria.
The sBLA was based on an international, multi-centre, double-blind, randomised, placebo-controlled Phase III trial involving about 250 adult patients with upper limb spasticity.
Conducted in the US, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary, the trial compared the efficacy of Dysport versus placebo in hemiparetic patients following a stroke or brain trauma.
The Phase III trial 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 trial's co-primary endpoints 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).
Additionally, Dysport's efficacy was evaluated on passive function as measured by the Disability Assessment Scale (DAS).
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."
According to the trial data, patients treated with Dysport showed a statistically significant improvement in muscle tone and a higher clinical benefit, versus placebo.
The company said that patients were offered the option to continue in an open label long-term study where they would receive additional treatment with Dysport for a total of 15 months.
Dysport is approved to treat upper limb spasticity in many international markets, but not in the US. The drug's only approved therapeutic indication in the US is for the treatment of adults with cervical dystonia.