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news.Ipsen has submitted a biologics license application for Dysport to the FDA for the treatment of patients with cervical dystonia.
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The biologics license application (BLA) submission relies on data from two pivotal Phase III studies performed in the US and abroad totalling 252 patients followed-up for up to 12 treatment cycles, in addition to substantial patient exposure in other clinical studies in cervical dystonia.
Dysport is a neuromuscular blocking toxin initially developed for the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia (a chronic condition in which the neck is twisted or deviated), spasticity of the lower limbs (heal) in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm.
Dysport has been granted orphan product status by the FDA as a treatment for cervical dystonia, an orphan disease in the US.
Jean-Luc Belingard, chairman and CEO of Ipsen, said: “The submission of the Dysport BLA to the FDA is a further sign of our strategic commitment to offer therapeutic responses for the care of patients with targeted medical conditions such as cervical dystonia.”