Auxilium Pharmaceuticals, Inc, a specialty biopharmaceutical company, announced that the US Food and Drug Administration's (FDA) Arthritis Advisory Committee will review Xiaflex during an advisory committee hearing, tentatively scheduled to take place on September 16, 2009. The Arthritis Advisory Committee is an official advisory committee of the FDA's Division of Anaesthesia, Analgesia and Rheumatology Products (DAARP). Advisory committees provide the FDA with independent expert advice on scientific, technical, and policy matters.
Xiaflex (collagenase clostridium histolyticum) is a novel, first-in-class, orphan-designated, biologic for the treatment of Dupuytren's contracture. Auxilium filed its Biologics License Application (BLA) for Xiaflex for the treatment of Dupuytren's contracture on February 27, 2009. The FDA has not updated the Prescription Drug User Fee Act (PDUFA) date of August 28, 2009.
"Since Xiaflex is a new molecular entity, we have been anticipating an advisory committee meeting," said Armando Anido, chief executive officer and president of Auxilium. "Due to administrative issues, the tentative committee date is just beyond the previously announced PDUFA date of August 28, 2009, but we are encouraged that the FDA advisory committee is looking at including hand and/or orthopaedic surgeons on the panel. We believe that the Xiaflex application supports a compelling benefit-risk profile of Xiaflex in the treatment of Dupuytren's contracture."
Auxilium Pharma is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopaedists and select primary care physicians.