Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has extended 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) programme 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 programme 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.
PD can affect men both physically and psychosocially. The disorder can result in varying degrees of penile curvature deformity, disease bother, sexual dysfunction, emotional distress, loss of self-esteem and depression. PD often involves the development of collagen plaque, or scar tissue, on the shaft of the penis that may harden and reduce flexibility, thus occasionally causing pain and bending or arcing of the penis during erection. In addition to difficulty with sexual intercourse, PD is commonly associated with emotional distress, loss of self-esteem, disease bother and depression.
Xiaflex (collagenase clostridium histolyticum; CCH) is a biologic approved in the US, EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord. Xiaflex is a minimally invasive treatment for this condition and consists of a highly purified combination of two subtypes of collagenase, derived from Clostridium histolyticum, in specific proportion. Together, the collagenase sub-types work synergistically to break the bonds of the triple helix collagen structure more effectively than human collagenase. CCH will be entering phase IIb of development for the treatment of Frozen Shoulder syndrome (adhesive capsulitis) and phase IIa of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Xiaflex has been granted Orphan status in the US by the FDA for DC and PD.
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences.