PARIS The Food and Drug Administration has issued a complete response letter to French drug maker Ipsen's approval application for Dysport.
Ipsen submitted its biologics license application for Dysport (botulinum toxin Type A) in 2007 as a treatment for cervical dystonia. In its letter, the FDA did not request any new clinical studies evaluating the efficacy or safety of the drug prior to approval, but did request the finalization of the risk evaluation and mitigation strategy, a safety update report and the draft labeling. Ipsen expects to submit the information in early 2009 and is preparing to launch the drug.
Cervical dystonia, also known as sposmadic torticollis, causes contractions of the neck and shoulder muscles. Dystonia diseases affect at least 300,000 people in the United States, according to the Dystonia Medical Research Foundation.