FDA To Review Xiaflex For Treatment Of Dupuytren’s Contracture

FDA’s Arthritis Advisory Committee has confirmed that it will review Auxilium’s Xiaflex during an advisory committee hearing at the Holiday Inn in Gaithersburg, MD, on September 16, 2009.

The Arthritis Advisory Committee is an official advisory committee of the FDA’s Division of Anesthesia, 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 on February 27, 2009. FDA has not updated the Prescription Drug User Fee Act (PDUFA) date of August 28, 2009, said the company.