Auxilium Pharma Says FDA Accepts Its SBLA Submission For Approval Of XIAFLEX

(RTTNews) - Auxilium Pharmaceuticals, Inc. (AUXL) said that the U.S. Food and Drug Administration FDA has accepted its submission of a supplemental Biologics License Application or sBLA requesting approval of XIAFLEX for the treatment of two Dupuytren's contracture or DC cords concurrently. The PDUFA date for the sBLA filing is October 20, 2014.

The company's Chief Executive and President stated, "We believe that a potential label expansion would provide a non-surgical option for treating two cords concurrently during one office procedure and we look forward to our PDUFA date later this year."

Dupuytren's contracture is a progressive hand disease that can present with multiple collagen "cords" that limit finger movement and hand function. It is anticipated that 35 to 40 percent of annual surgical procedures in the U.S. are performed to treat more than one DC cord at a time. The sBLA, seeking expansion of the labeling for the concurrent treatment of two palpable cords, is based on positive results from the global, multicenter Phase 3b MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) trial, together with data from the Company's earlier studies (AUX-CC-861 and AUX-CC-864).

Also, the study examined the efficacy and safety of the finger extension procedure at 24, 48 or 72 hours post injection.