Ipsen receives FDA complete response letter for Dysport’s BLA

The application, submitted previously by the group in late 2007, seeks approval to market Dysport for the treatment of cervical dystonia. The group said that it is now actively preparing to launch the product, once approved by the FDA, and as soon as reimbursement coverage is adequate.

The FDA has not requested any new clinical studies evaluating the efficacy or safety of Dysport prior to approval. The complete response letter requests additional information, including the finalization of the risk evaluation and mitigation strategy and of the draft labeling, as well as a safety update report.

Based on the information identified in the FDA’s end of review complete response letter, Ipsen expects to submit the information to the FDA during the first quarter of 2009.

Furthermore, the FDA has confirmed in its establishment inspection report that the manufacturing process for Dysport in Ipsen’s Wrexham (Wales) facility is in compliance with current good manufacturing practices.

Stephane Thiroloix, executive vice president of corporate development at Ipsen, said: We are confident that we can expeditiously respond to the questions set forth in the complete response letter. We anticipate answering to the FDA during the first quarter of 2009 and remain focused on bringing Dysport to market as originally planned.