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Ipsen has submitted a Biologics License Application (BLA) for its cervical dystonia treatment to the US Food and Drug Administration (FDA).
Dysport (clostridium botulinum type A toxin-haemagglutinin complex) will now be assessed by the regulator to justify the final review by the Center for Drug Evaluation and Research.
The BLA submission relies on data from two pivotal phase III studies performed in the United States and abroad totalling 252 patients, who were followed up for up to 12 treatment cycles, in addition to substantial patient exposure in other clinical studies in cervical dystonia.
Cervical dystonia, sometimes known as spasmodic torticollis, is a focal dystonia of the neck and typically occurs in people over the age of 40.
By causing neck muscles to contract involuntarily, it produces abnormal movements of the neck and head.
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.
“I am pleased that we were able to submit this application in the planned timeframe. Further to Somatuline Depot’s approval by FDA in August, a new successful milestone has been achieved in Ipsen’s international development strategy in specialised care.”
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