Arthritis Advisory Committee Confirms Date To Review Xiaflex

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.

Xiaflex (collagenase clostridium histolyticum) is a novel, orphan-designated, biologic for the treatment of Dupuytren’s contracture. Auxilium had filed 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.

Auxilium is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. The company has currently five projects in various stages of clinical development.