Auxilium seeks FDA approval for XIAFLEX sBLA to treat multiple Dupuytren's contracture cords concurrently

Dec 20 2013

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) requesting approval of XIAFLEX (collagenase clostridium histolyticum, or CCH)  for the treatment of multiple Dupuytren's contracture (DC) cords concurrently. It is estimated 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. XIAFLEX is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.

"We are pleased to present the multicord sBLA filing to the FDA ahead of schedule, especially given the estimated high prevalence of multiple cords among patients suffering from Dupuytren's contracture," said Adrian Adams, Chief Executive Officer and President of Auxilium. "This is an important milestone for Auxilium and, importantly, for patients, as we believe that a potential label expansion would provide a non-surgical option for treating multiple cords during one office procedure."

The sBLA, seeking expansion of the labeling for the concurrent treatment of multiple palpable cords, is based on positive results from a global, multicenter Phase 3b trial, together with data from the Company's earlier MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) studies (AUX-CC-861 and AUX-CC-864).