Delays for Ipsen BLA as FDA wants more data

French drugmaker Ipsen says that the US Food and Drug Administration has issued a complete response letter delaying the Biologics License  Application for its botulinum toxin Type A, Dysport, for the treatment  of cervical dystonia.

The FDA has requested additional information for the application,  including the finalization of the risk evaluation and mitigation  strategy and of the draft labeling, as well as a safety update report.  The agency has not requested any further trials.

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