FDA approves supplemental BLA for Ipsen's Dysport

The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for Dysport (abobotulinumtoxinA) from French drugmaker Ipsen (Euronext: IPN) to treat upper limb spacisity in adult patients.

Following this approval, Dysport is now approved for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors, with clinical improvement expected one week after administration.

Most patients in clinical studies were retreated between 12 and 16 weeks, and some patients had a duration of response as long as 20 weeks.