MALVERN, Pennsylvania—Auxilium Pharmaceuticals, Inc has asked the US FDA to fast-track its Biologics License Application (BLA) for Xiaflex™ (clostridial collagenase for injection) for treatment of Dupuytren's contracture. If approved, the drug (a novel, first-in-class, orphan-designated biologic) would be the first nonsurgical treatment approved for this disorder.

"This BLA submission is a significant regulatory milestone for Xiaflex," said Armando Anido, Chief Executive Officer and President of Auxilium. "There currently are no approved non-surgical treatments available for Dupuytren's contracture, which can be a debilitating disease that often affects patients' quality of life. We believe that Xiaflex, if approved, would be the non-surgical treatment choice for the management of Dupuytren's contracture and could meaningfully improve the lives of patients diagnosed with the disease. We look forward to working with the FDA as it reviews the Xiaflex application."

The BLA submission includes data from a pivotal phase III trial (the CORD-I study) and included 1082 patients treated with over 2600 injections of Xiaflex.

Tiny shot of Xiaflex, then “pop” the Dupuytren's cord

The novel noninvasive treatment, which was also discussed in a press briefing at the recent 2009 American Academy of Orthopaedics meeting, uses injections of a small amount of the enzyme into the collagen-based cord, which develops in the palm of Duputren's patients and causes contractures of the fingers. This weakens the strand of pathologic tissue, which can then be broken with simple extension and manipulation, restoring more normal movement to the hand.

Auxilium expects to hear back from the FDA on Priority Review designation within approximately 60 days from the filing date, which was March 2, 2009. If granted, the FDA, per Prescription Drug User Fee Act guidelines, has up to six months from submission date to take action on the BLA. Priority Review may be granted to drug products that provide treatment when no approved pharmacological treatments exist for a disease.