FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX

Aug 28 2013

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") has notified the Company that it is extending the Prescription Drug User Fee Act ("PDUFA") goal date for the Company's supplemental biologics license application ("sBLA") for XIAFLEX^® (collagenase clostridium histolyticum) for the treatment of Peyronie's disease ("PD") from September 6, 2013 to December 6, 2013.

During the course of recent product label discussions, Auxilium submitted revisions regarding the Company's proposed Risk Evaluation and Mitigation Strategy (REMS) program and other aspects related to the proposed label. The FDA determined that this submission qualified as a major amendment filed during the final three months of the review and extended the PDUFA goal date to December 6, 2013.  The FDA has not requested that any additional clinical studies be performed prior to the revised PDUFA action date.

"While we are disappointed in any delay of approval, we remain confident in the XIAFLEX Peyronie's program and are committed to working with the FDA while they complete their review," said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals. "We are continuing to prepare for commercialization in Peyronie's disease, assuming FDA approval by the revised PDUFA date."

PD is a condition in which collagen scar tissue may develop under the skin of the penis. The scar tissue, known as a Peyronie's plaque, can feel like a bump and cause the penis to curve or bend when erect. This curvature deformity of the penis can impact sexual intercourse, erections and erection appearance, and can cause affected men to feel bothered, distressed, depressed or embarrassed.

Auxilium submitted to FDA the safety and efficacy data from the pivotal IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the Phase III studies that assessed XIAFLEX for the treatment of PD. In IMPRESS I and IMPRESS II at 52 weeks, both co-primary endpoints met statistical significance for mean percent improvement in penile curvature deformity and mean improvement in the PDQ bother domain for XIAFLEX subjects vs. placebo patients. XIAFLEX was generally well-tolerated.